The primary purpose of the clinical investigation is to verify the SpO2 accuracy of the Philips AlarX5 SpO2 sensor with Nellcor OxiMax SpO2 Board.
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
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 limit the ability to test sites needed for the study. Tattoos (e.g. permanent, Henna) or artificial dyes (e.g. spray tan, artificial tanning lotion) in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
Females who are pregnant
Females who are trying to get pregnant with confirmation of positive urine pregnancy test
The study population will include a minimum of 36 to 72 healthy adult volunteers.
Other
Prospective
Evaluation of Oxygen Sensors
Other interventionThe 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)
Measurement and comparison of SpO2 accuracy of the AlarX5 SpO2 sensor (nasal ala application) compared to arterial oxygen saturation.
Measurement and comparison of SpO2 accuracy of the AlarX5 SpO2 sensor (nasal ala application) compared to arterial oxygen saturation.
Measurement and comparison of SpO2 accuracy of the AlarX5 SpO2 sensor (earlobe placement) during non-motion conditions.
Measurement and comparison of SpO2 accuracy of the AlarX5 SpO2 sensor (earlobe placement) during non-motion conditions.
Evaluation of the pigmentation bias of the AlarX5 SpO2 sensor (nasal ala and earlobe application).
Non-disparate performance for the AlarX5 SpO2 sensor.
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