Introduction

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This User Guide contains essential information for the proper operation of the B4C System. It aims to familiarize you with all system functions, guide you through portal usage.

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.

Target population

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

Collateral or side effects

Allergic reactions due to hypersensitivity to sensor components.

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.