Validate the performance of Philips FAST SpO2 with Masimo Pulse Oximetry Sensors in determining functional arterial oxygen saturation (SpO2) using arterial saturation (SaO2) as a reference in the range of 70-100% in subjects of varying skin pigmentation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
70
Noninvasive pulse oximeter
Masimo Corporation
Irvine, California, United States
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt)
The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.
Time frame: 1 hour
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt CS)
The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt CS) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.
Time frame: 1 hour
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® YI)
The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® YI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.
Time frame: 1 hour
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DBI)
The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® DBI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.
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Time frame: 1 hour
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (LNCS® Adtx)
The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (LNCS® Adtx) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.
Time frame: 1 hour
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® TC-I)
The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® TC-I) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.
Time frame: 1 hour
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DCI)
The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® DCI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection.
Time frame: 1 hour