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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.

Image Modified 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.

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

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.

The position, or movement, of the patient and the BcSs-PICNIW-1000/BcSs-PICNIW-2000 sensors 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

Do not press the BcSs-PICNIW-1000/BcSs-PICNIW-2000 sensor pin with hand or any other object, this may damage the sensor.

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.

The signal quality check is NOT a clinical judgement or diagnosis. The is a technical verification and the insufficient signal quality message means one or more of the four conditions below are true:

• The signal-to-noise ratio is not satisfactory (signal with lack of physiological characteristics)

• The amount of artifacts is excessive (too much movement being captured in the signal)

• The processed signal will result in a statistically non-significant P2/P1 ratio

• Processed signal will result in a non-physiological Time-to-Peak range

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

Verify with your facility’s clinical engineering team which receiver will match the monitor module plug in your care giving area.

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

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.