warnings and precautions

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:

• 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.

Do NOT attempt to calibrate the sensor (BcSs-PICNIW-1000 ou BcSs-PICNIW-2000) 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 sensor (BcSs-PICNIW-1000 ou BcSs-PICNIW-2000) is connected. Make sure that the default question marks (? /?) or dashes (- / -) are shown instead.

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 expose the sensor to heat sources. Excessive temperature can cause leaks and excessive heat can cause physical injury.

The wireless charging system may warm up and heat the sensor while charging to temperatures slightly above the ambient temperature. The sensor features overheating technology to prevent damage. However, it's important to check the product temperature before operating the sensor.

Caution and attention when handling the sensor tape due to the risk of strangulation.

Keep the equipment away from children. There is a risk of the equipment releasing small parts that can be swallowed and cause choking.

The sensor is a sensitive device that should be handled with care. Avoid leaving it within reach of pets and children.

The operator should not touch the patient and the cabinet of a non-electromedical equipment simultaneously.

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.

Only the original power supply and cables should be used with the charger. If not there is a risk of charger malfunction. Do not insert conductive objects in the magnetic connector. Metallic materials can be attracted by the magnetic connector and cause a short-circuit

If the equipment is not used for a long period of time, the external battery should be removed.