SpO2 Verification Study - Philips Nasal Alar With Nellcor OxiMax SpO2 Board (453564624031)
Philips Clinical & Medical Affairs Global
Summary
The primary purpose of the clinical investigation is to verify the SpO2 accuracy of the Philips AlarX5 SpO2 sensor with Nellcor OxiMax SpO2 Board.
Description
To verify the SpO2 accuracy of the AlarX5 SpO2 sensor (nasal ala application) with the Nellcor OxiMax pulse oximetry technology 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 Exclusion Criteria: * Participant is considered as being morbidly obese (defined as BMI \>39.5) * Compromised circulation (i.e., Raynaud's Syndrome), injury, or physical malformation of fingers, hands, nose, ears or forehead/skull or other sensor sites which would lim…
Interventions
- OtherEvaluation of Oxygen Sensors
The experimental Philips AlarX5 SpO2 sensor will be tested with Nellcor OxiMax pulse oximetry technology. The AlarX5 SpO2 sensor will be connected via an adapter cable to an IntelliVue X3 Patient Monitor integrated with a Nellcor OxiMax SpO2 Board. Within the study, biomedical/health related outcomes as it relates to the healthy volunteers are not evaluated. The data collected will be used to evaluate how accurate the pulse oximeter (DUT) is to the reference. Devices under test are listed below: * Nellcor OxiMax SpO2 Board (453564624031) integrated within Philips IntelliVue X3 Patient Monitor (867030) * Philips AlarX5, Experimental SpO2 sensor based on the Nasal Alar design (nasal ala and earlobe placement) * Philips M1943NL SpO2 Adapter Cable (3m)
Location
- Element Materials TechnologyLouisville, Colorado