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Comment: Revised warning that B4C System has not been validated to be a substitute for invasive ICP monitoring to match updated warning statement requested by FDA

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Warning

WARNING - The BcSs-PICNIW-1000 Sensor 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.

Warning

WARNING - The BcSs-PICNIW-1000 Sensor and waveform output do not substitute ICP monitoring methods when measurement of the absolute value of ICP is requiredB4C System has not been validated to be a substitute for invasive ICP monitoring methods in any cases.

Warning

WARNING - The medical professional is responsible for determining the additional clinical parameters or analyses required in addition to the BcSs-PICNIW-1000 Sensor waveform to make a clinically informed decision.

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