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The B4C System is designed to provide for non-invasive monitoring of variation in intracranial pressure (ICP) variations. The system ONLY It monitors only the intracranial pressure ( ICP ) pulse morphology, which is shown displaying it as a surrogate ICP waveform on the brain4care application or, with the use of the optional dongle, show the sensor waveform in on a compatible multiparameter monitor. The monitor that must have an Invasive Blood Pressure (IBP) or Invasive Pressure (IP) Module with sensitivities of 5 μV/Vex/mmHg or higher and have automatic amplitude window adjustment.
Important:
This system does NOT
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measure actual pressure in mmHg.
The signal
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displayed on the mobile application or patient monitor should be
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interpreted based solely on its waveform morphology, not its absolute ICP value.
The BcSsPICNIW-1000
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Sensor and B4C System
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are not intended
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to be used as
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standalone diagnostic
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tools. The surrogate ICP waveform
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should be considered as one element
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within a
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broader clinical evaluation.
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ATTENTION - This sensor does NOT monitor measure ICP in mmHg and therefore . Therefore, the waveform shown in a displayed on the monitor should be assessed only solely by its morphology and NOT , not by its absolute value.
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3.1.1 indications for use
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| Warning |
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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 decompression 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.