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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

6.7.1. sensor placement instructions

Assessing the braincare brain4care waveform

The best position for ICP waveform monitoring is a resting supine position at 30 degrees with the chin and sternum aligned (Figure 6.7-1) and the head should not be tilted. The patient must be resting and avoid any movements since that can interfere with the ICP waveform reading.

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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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Info

ATTENTION - Trained Personnel are expected to recognize proper waveform quality.

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Warning

WARNING - Do NOT attempt to calibrate BcSs-PICNIW-1000 Sensor with your patient monitor. This may result in display of a misleading ICP value shown in the patient monitor that can be misinterpreted when making critical clinical decisions.

Warning

WARNING - Make sure NO ICP value is shown in your patient monitor when the BcSs-PICNIW-1000 Sensor is connected. Make sure that the default question marks (? /?) or dashes (- / -) are shown instead.

Info

ATTENTION - Only use with a compatible monitors and DO NOT calibrate the ICP value (mmHg)