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The CipherOx™ CRI MI is indicated for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor),and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia. For patients with a finger thickness of 0.3'' to 1'' in hospital and pre-hospital settings. CRI trends with changes in intravascular volume relative to the individual patient's response to hypovolemia, and should only be used by qualified medical providers as an adjunct to rather than as a replacement for traditional hemodynamic measures. CRI is indicated for adults (19-36 years old) in the supine position under non-motion conditions and without cardiovascular disease. CRI has not been studied in trauma patients.

The CipherOx CRI™ M1 is a modification of the predicate device, the CipherOx CRI Tablet (DEN160020). The M1 is a smaller version of the Tablet that is designed for increased portability. The CipherOx CRITM M1 is a non-invasive, continuous, and multi-parameter monitor that displays SpO2, HR, and the Compensatory Reserve Index (CRI). CRITM is a physiologic parameter that trends changes in intravascular volume, which help to assess a patient's hemodynamic status. The CRI™ algorithm trends intravascular volume using non-invasive arterial pulsatile waveform signals by continuously comparing extracted waveforms to a reference model. CipherOx™ CRI system operates on the photoplethysmograph (PPG) waveform used in pulse oximetry to estimate CRI. The CipherOx CRI™ M1 incorporates: - 1. CRI™ algorithm - Nonin pulse ox sensor (8000AA K080255) 2. - 3. M1 User Interface module which is a small, portable, battery powered unit that displays heart rate. SpO2, and CRI™.

The CipherOx CRI Tablet is indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia. For patients with a finger thickness of 0.3" to 1" in hospital and pre-hospital settings. CRI trends with changes in intravascular volume relative to the individual patient's response to hypovolemia, and should only be used by qualified medical providers as an adjunct to rather than as a replacement for traditional hemodynamic measures. CRI is indicated for adults (19-36 years old) in the supine position under non-motion conditions and without cardiovascular disease. CRI has not been studied in trauma patients.

The CipherOx CRI Tablet consists of a Nonin Onyx II Model 9560 finger pulse oximeter (previously cleared under K081285) that communicates by Bluetooth with a Cybernet CyberMed T10 tablet PC. The CipherOx CRI Tablet is a continuous, multi-parameter monitor that displays SpO2, Heart Rate (HR), photoplethysmograph (PPG) waveform images, and the Compensatory Reserve Index (CRI) value and historical trend-line. CRI is an index related to the physiologic changes induced by intravascular fluid loss and ranges from 0 to 1, where 1 indicates a normal subject and 0 indicates a subject who has undergone significant physiological effects from loss of fluid volume.