Modification to Onyx Finger Clip Pulse Oximeter Model 9500

FDA-Cleared Indications

• Noninvasive measurement of arterial oxygen saturation (SpO2)
• Measurement of pulse rate

Clinical Applications

• Checking oxygen saturation and pulse rate during routine clinical assessment
• Monitoring oxygenation and pulse rate in patients with suspected or known respiratory disease
• Monitoring patients during anesthesia and other clinical care
• Monitoring patients in hospital, outpatient, or home-care settings when pulse oximetry is indicated

Reported off-label uses

• Screening for changes in oxygenation during exercise or ambulation
• Spot-checking oxygen saturation during sleep-related evaluations

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The clip is placed on a finger with the light-emitting diodes and photodetector aligned across the tissue. Motion, poor circulation, cold fingers, nail products, or incorrect placement can affect readings.
• The device is intended for noninvasive use and is battery operated. Follow the manufacturer’s instructions for cleaning, battery replacement, and verification of proper operation.
• Use the labeled patient-size range and confirm that the clip fits securely without causing discomfort. Pediatric use should follow the device labeling and institutional policy.
• This device should not be used as the sole basis for diagnosis or treatment; readings must be interpreted with the patient’s clinical condition and other measurements.
• The device should not be taken into an MRI environment unless the manufacturer’s labeling specifically identifies it as MRI safe or MRI conditional. Keep it outside the MRI scanner room unless cleared for that environment.