SpO2 Verification Study - Philips Nasal Alar With Nellcor OxiMax SpO2 Board (453564624031)

Conditions

• Pulse Oximetry

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• Evaluation of Oxygen Sensors — OTHER
  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)

Study Details

The primary purpose of the clinical investigation is to verify the SpO2 accuracy of the Philips AlarX5 SpO2 sensor with Nellcor OxiMax SpO2 Board.

Key Dates

Start date

May 28, 2026

Status verified

Jun 2026

Primary completion

Jun 24, 2026

Completion

Jun 24, 2026

Study Design

Enrollment

45 participants (estimated)

Arms

• Arm: Healthy Volunteers
  Participants are healthy, non-smoking (or has refrained from smoking for 2 days) competent adults, ages 18 to 50 years.

Primary Outcome Measure

Measurement and comparison of SpO2 accuracy of the AlarX5 SpO2 sensor (nasal ala application) compared to arterial oxygen saturation. [ Time Frame: Up to 6 weeks ]

Central Contacts

• Dominque Watson
  724-334-3117
  [email protected]

Locations (1)

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