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Warning

WARNINGS

  • The B4C System should only be used by trained and qualified health professionals.

  • 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 BcSs-PICNIW-1000 Sensor and waveform and report output do not substitute ICP monitoring methods when measurement of the absolute value of ICP is required.

  • The medical professional is responsible for determining the additional clinical parameters or analyses required in addition to the BcSs-PICNIW-1000 Sensor 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.

  • 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.

  • 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.

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  • MR Unsafe. The B4C System is not intended to be used in an MR (magnetic resonance) environment.

  • The type of protection of the sensor is IP00. So, keep the sensor and the receiver away from water or any type of liquids, to prevent any damage to the sensor or to the patient.

  • Do not leave the equipment near flammable chemicals such as alcohol, benzene, etc. Should they come in contact with electrical parts, this may result in fire or internal short circuit. The same is true with the use of some flammable disinfectants.

  • 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.

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