SpO2 Validation Study-Philips Optimus

Conditions

• Pulse Oximetry, Oxygen Measurements, SpO2

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• No intervention — DEVICE
  No intervention

Study Details

Validation study 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

Key Dates

First listed

Oct 10, 2025

Start date

Sep 9, 2025

Status verified

Apr 2026

Primary completion

Sep 19, 2025

Completion

Sep 19, 2025

Study Design

Enrollment

24 participants (actual)

Arms

• Arm: Philips Wireless Patient Module SpO2 (Gen-4)
  This device is a complete pulse oximeter measurement module that utilizes the Philips PicoSAT II+ SpO2 processor that is a component on the circuit car assembly, part number 453665151651. This processor incorporates all signal processing and algorithms to derive the oxygen saturation value (SpO2), pulse rate, perfusion indicator value, and the plethysmographic waveform
• Arm: SpO2 Sensor, MRI (Gen-4)
  This is a fiber-optic cable that is attached via an connector at one end to the Philips Wireless SpO2 Patient Module, and one of the SpO2 finger accessories at the other end. This cable serves as the conduit through which red and infrared light is transmitted into the finger and then is received back from the other side of the finger into the photodiode. The red and infrared LEDs and the photodiode are all contained in the cable housing. The cable itself is made from RoHS-compliant fiber-optic materials. Fiber-optics are utilized to allow the SpO2 module to operate properly in the MRI environment.
• Arm: SpO2 Accessories: SpO2 Grips (Single Use) and SpO2 Gloves (Reusable)
  The SpO2 Grips and Gloves are designed to securely hold the SpO2 Sensor in proper location when it is attached to the Wireless SpO2 module. Both finger accessories provide two slide-in clip attachments for connecting to the SpO2 Cable ends, designed to be positioned at the top and bottom of the finger. The reusable finger accessory is designed to slide onto the finger and secure itself by means of a rubber-like material that provides the appropriate grip
• Arm: Silver Reference: IntelliVue Patient Monitor X3 and Adult SpO2 Sensor (M1191BL)
  The IntelliVue X3 is a versatile patient monitoring device with a color touchscreen display. It can simultaneously monitor ECG (using 3-, 5-, 6- or 10-lead sets, including arrhythmia and ST monitoring), respiration, SpO2, NBP, two invasive pressures, temperature, and CO2. The multi-touch screen allows easy interaction by swiping and tapping with one or two fingers.

Primary Outcome Measure

SpO2 accuracy of the SpO2 sensors under test with the Philips MRI Patient Monitoring [ Time Frame: Day 1 ]

Locations (1)

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