3.1 purpose of use

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The B4C System is designed for non-invasive monitoring of intracranial pressure (ICP) variations. It monitors only the ICP pulse morphology, displaying it as a surrogate ICP waveform on the brain4care application or, with the optional dongle, on a compatible multiparameter monitor. The monitor must have an Invasive Blood Pressure (IBP) or Invasive Pressure (IP) Module with sensitivities of 5 μV/Vex/mmHg or higher and automatic amplitude window adjustment.

Important:

This system does NOT measure actual pressure in mmHg.
The signal displayed on the mobile application or patient monitor should be interpreted based solely on its waveform morphology, not its absolute ICP value.
The BcSsPICNIW-1000 Sensor and B4C System are not intended to be used as standalone diagnostic tools. The surrogate ICP waveform should be considered as one element within a broader clinical evaluation.

ATTENTION - This sensor does NOT measure ICP in mmHg. Therefore, the waveform displayed on the monitor should be assessed solely by its morphology, not by its absolute value.

1 3.1.1 indications for use
2 3.1.2 target population
3 3.1.3 collateral or side effects
4 3.1.4 contraindications

3.1.1 indications for use

The B4C System is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance, by providing surrogate ICP waveforms and associated parameters (estimated P2/P1 ratio, normalized Time-to-Peak, derived useful ICP pulses and cardiac pulse) for interpretation.

Refer to device labeling for more information regarding the derivation and interpretation of the output of the device.

WARNING - This sensor 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.

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3.1.2 target population

Adult patients ages 18 years of age or older with suspected intracranial hypertension or changes in intracranial compliance.

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3.1.3 collateral or side effects

Allergic reactions due to hypersensitivity to sensor components.

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3.1.4 contraindications

The system is contraindicated for use in patients under 18 years of age.

The system is contraindicated for use in adult patients 18 years of age or older who have:

Undergone decompressive craniectomy;
Cranial defects (portions of skull missing);
Patients with hypersensitivity to sensor components;
Any other conditions that the healthcare professional deems unsuitable for use of this device.

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