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Comment: Updated precaution statement per FDA request on 10/6 to change "predicted value" to "estimated value"

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 requiredB4C 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 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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  • Multiple scalp injuries that make it impossible to correctly position the sensor;

  • Open head wounds;

  • Any other conditions the health practitioner deems to be unsuitable for use of this device.

Note

PRECAUTIONPRECAUTIONS

  • The position, or movement, of the patient and the BcSs-PICNIW-1000 Sensor is known to affect the signal being recorded. As a result, if multiple recording sessions are obtained on the same patient, consistent positioning of the patient and device will lead to more comparable recordings

  • The derived P2/P1 ratio is 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.

  • Contact brain4care to receive training before operating the BcSs-PICNIW-1000 Sensor. The sensor may only be used by qualified individuals who have successfully completed training with a brain4care representative.

  • Read and understand the content of this user guide before use.

  • Manually clean and disinfect the device components before and after each patient’s monitoring session.

  • Do not subject the device to autoclave or other thermal disinfection or sterilization processes.

  • Perform corrective maintenance once a year, and if abnormal performance is observed.

  • All modifications and repairs must be exclusively performed by brain4care.

  • When disinfecting the sensor pin be careful to not apply excessive force.

  • If the device functionalities are lost due to EM disturbances, the waveform may not be accurate.

  • Ensure that your mobile device is set up with a strong password, not used in root mode, nor with unverified applications installed.

  • Never share your password and user ID with others or write down your password in an easily accessible place.

  • Verify with your facility’s clinical engineering team which receiver will match the monitor module plug in your caregiving area.If the Essential Performance is lost due to EM disturbances, the waveform may not be accurate.

  • Be cautious when handling the headband due to risk of strangulation. Also avoid touching simultaneously the patient and a non medical device due to risk of electrical shock

  • The use of the B4C wireless sensor adjacent to or stacked with other equipment should be avoided. If such use is necessary, the device and the other equipment should be observed to verify that they are operating normally

  • Only original charging cables and accessories shipped with the B4C System should be used. Do not use them in any other equipment or device. The use of accessories other than those specified may result in increased emissions or decreased immunity of the device.

  • The B4C System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the B4C System helps to prevent electromagnetic interference by maintaining a minimum distance of 30cm (12 inches) between portable or mobile RF communication equipment (transmitters) and the B4C System.

  • The B4C System may be affected by equipment that emits RF signals in the environment in which it is installed. Using the device close to RFID readers can cause temporary loss of wireless functionalities.