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Comment: Updated precaution statement per FDA request on 10/6 to replace "predicated value" with "estimated value"

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Info

ATTENTION - These estimated P2/P1 peaks identified in this report are the most likely P1 and P2 derived from a statistical model based on the cardiac cycle of patients. The estimated P2/ P1 ratio shows the value of the division between the amplitude of peak P2 and the amplitude of peak P1. Values above 1.0 indicate that P2 is greater than P1 when monitored with the brain4care sensor.

Info

ATTENTION - The B4C System is an operator dependent device that contains inherent variances and as such all confidence intervals should be considered by the health professional during interpretation of estimated waveform associated parameters. 

Info

ATTENTION - The B4C surrogate waveform and estimated associated parameters are intended to be utilized to monitor relative variation in an individual patient’s intracranial pressure over time.

Note

PRECAUTION - The derived P2/P1 ratio is a predicted an estimated value and therefore carries some uncertainty. The clinician is reminded to use their professional judgment when interpreting this and all waveform information in the report.

Warning

WARNING - The B4C System does not replace a comprehensive clinical evaluation. The waveform output should always be evaluated by the clinician in conjunction with other clinical parameters or analyses

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