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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.
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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.
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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.
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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.
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