SPO2 NEXT GEN VALIDATION STUDY - PHILIPS OPTIMUS
Philips Clinical & Medical Affairs Global
Summary
The purpose of this clinical study is to validate the SpO2 accuracy performance of the sponsor's SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry.
Description
To validate the SpO2 accuracy of the SpO2 sensors under test with the Philips MRI Patient Monitoring Pulse Oximetry Subsystem during non-motion conditions over the range of 70-100% SaO2, when compared with the reference SaO2 obtained from CO-Oximetry analysis of arterial blood samples.
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Participant must have the ability to understand and provide written informed consent. * Participant is an adult between 18-50 years of age. * Participant must be willing and able to comply with study procedures and duration. * Participant is a non-smoker or who has not smoked within 2 days prior to the study. * Male or female assigned at birth of any race. Exclusion Criteria: * Participant is considered as being morbidly obese (defined as BMI \>39.5) * Compromised circulation (i.e., Raynaud's Syndrome), injury, open wound, or physical malformation of fingers, toes, han…
Interventions
- DevicePhilips MR400 Pro MRI Patient Monitor
Philips IntelliVue Patient Monitor X3 Philips Adult SpO2 Sensor (M1191BL) Philips Wireless Patient Module SpO2 (Gen-4) SpO2 Sensor, MRI (Gen-4) Adult SpO2 Glove Adult SpO2 Grips
Location
- Element Materials TechnologyLouisville, Colorado