WARNINGS - Device operation and output interpretation The B4C System must only be operated by trained and qualified health professionals, who are responsible for knowing the protocol guiding usage of the sensor as well as the care related to its purpose and use in patients. The B4C System does not replace a comprehensive clinical evaluation. The waveform and report output should always be evaluated by the clinician in conjunction with other clinical parameters or analyses. The B4C System has not been validated to be a substitute for invasive ICP monitoring methods in any cases. The medical professional is responsible for determining the additional clinical parameters or analyses required in addition to the sensor (BcSs-PICNIW-1000 or BcSs-PICNIW-2000) waveform and report to make a clinically informed decision. The appearance of a normal waveform morphology and report information does not eliminate the possibility of elevated intracranial pressure or irregularity in brain compliance. The clinician is reminded to assess the waveform morphology in real-time during a monitoring session. The B4C report is available for the clinician’s convenience to review associated waveform parameter estimates and other clinical observations entered in a past monitoring session. Do not use this device on patients who have:
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