3.1 purpose of use

The B4C System is designed to provide non-invasive monitoring of variation in intracranial pressure (ICP). The system ONLY monitors the intracranial pressure (ICP) pulse morphology, which is shown as a surrogate ICP waveform on the brain4care application or, with the use of the optional dongle, show the sensor waveform in a compatible multiparameter monitor that have Invasive Blood Pressure (IBP) or Invasive Pressure (IP) Module with sensitivities of 5 μV / Vex / mmHg or higher and have automatic amplitude window adjustment. This system does NOT monitor actual pressure in mmHg. The signal shown on the mobile application or patient monitor should be assessed only by its morphology and NOT by its ICP absolute value. The BcSsPICNIW-1000 / Sensor and B4C System is not intended for use as a standalone diagnostic tool. The surrogate ICP waveform is one element of a comprehensive clinical evaluation.

ATTENTION - This sensor does NOT monitor ICP in mmHg and therefore the waveform shown in a monitor should be assessed only by its morphology and NOT absolute value.

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.

3.1.2 target population

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

3.1.3 collateral or side effects

Allergic reactions due to hypersensitivity to sensor components.

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 decompression 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.