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Core Components
Portal
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ATTENTION - Please read the entire user guide before using the B4C System. |
It is a secure and private online environment for generating, viewing and sharing B4C reports, with associated parameters, for patients. A corporate account is used to manage which users will have access to the corporate account and their respective access profiles, in addition to the possibility of viewing reports made by that user or organization. Access to the corporate account is restricted to authorized users. A legal entity (hospital or clinic) will have an organization created by brain4care after having licensed the B4C system
Physio Core
Physio Core is a sub-component of the B4C System. It is the analytical engine that receives sensor’s raw morphology data via mobile device, processes the data and generates monitoring reports with processed surrogate ICP waveforms and associated parameters (no medical conclusions or recommendations are generated).
Important definitions
User Profile: information that uniquely identifies a person registered in the B4C System.
Corporate Account | Corporate Profile: a private and secure environment created for a legal entity which has licensed the B4C System, i.e, a hospital or clinic.
Username: a unique portal identity created for each registered individual.
Organization | Corporate Account: a unique portal entity created for each registered client (hospital/clinic), i.e., corporate account.
Organization Member: a B4C System user profile linked to an organization/corporate account.
Access Profile: a set of authorizations granted to a member in a corporate account.
Organizational unit:: a subdivision of an organization where members can be grouped.
Applications | Modules: functional areas in the portal that are available based on user profiles.
Notifications: portal-generated messages that are posted in the notification area.
Protocol or UMI: a unique identifier generated for each monitoring session performed by a healthcare professional.
Devices: mobile devices that can be managed and defined as blocked, normal use or secure.
UID or UDI: a sensor’s unique identifier (unique ID = UID or unique device ID = UDI). Each sensor, external battery and receiver have their unique identifier. It is used on each protocol (first six digits of an UMI)
back to topThis 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.