This user guide is for the Portal cloud components of the B4C System. If you are looking for usage information for the Sensor and Mobile App components please refer to the SENSOR USER GUIDE /wiki/spaces/B4CGUIDEAPP/pages/2390687768. Please read the brain4care portal information carefully. This guide provides information necessary for the proper operation of the brain4care Wireless Monitoring System platform. Please, READ IT CAREFULLY. If in doubt, For any questions please reach out to our technical team for guidance. The brain4care platform was developed following the most advanced information security concepts and compliance to the protocols and is compliant with General Data Protection Act (LGPD, Brazil) and the Health Insurance Portability and Accountability Act (HIPAA, USA). Its The architecture ensures internal anonymization de-identification of patient data while allowing healthcare professionals, who are licensed to use the wireless noninvasive intracranial pressure monitoring system, to view and analyze intracranial pressure morphology data. This secure architecture does NOT preclude the existence of some rules that must be fully followed by users for the correct use and operation of the platform:
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Always use nationally or internationally recognized scientific protocols for sensor use and data analysis on the portal.
The proper functioning of the platform depends on installing the Google Chrome, Microsoft Edge, or Firefox browser on your computer, laptop, or tablet; which must have an appropriate . Appropriate internet connection is also required.
Read this user guide fully, as many questions can be avoided by simply by knowing the platform’s embedded functions.
The figures images presented in this manual are for illustration purposes only.
Please refer to the SENSOR GUIDE /wiki/spaces/B4CGUIDEAPP/pages/2390687768 for more information regarding the interpretation of the report information
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Undergone decompression craniectomy;
Cranial defects (missing skull portion);
Patients with hypersensitivity to sensor components;
Other conditions that the healthcare professional deems unsuitable for use of this device.
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WARNINGS
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Do not use this device on patients who have:
Multiple scalp injuries that make it impossible to correctly position the sensor;
Open head wounds;
Any other conditions the health practitioner deems to be unsuitable for use of this device.
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PRECAUTIONS
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The position, or movement, of the patient and the BcSs-PICNIW-1000 Sensor are known to affect the signal being recorded. As a result, if multiple recording sessions are obtained on the same patient, consistent positioning of the patient and device will lead to more comparable recordings
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The derived P2/P1 ratio is a predicted value and therefore carries some uncertainty. The clinician is reminded to use their professional judgment when interpreting this and all waveform information in the report.
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Contact brain4care to receive training before operating the BcSs-PICNIW-1000 Sensor. The sensor may only be used by qualified individuals who have successfully completed training with a brain4care representative.
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Read and understand the content of this user guide before use.
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Manually clean and disinfect the device components before and after each patient’s monitoring session.
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Do not subject the device to autoclave or other thermal disinfection or sterilization processes.
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Perform corrective maintenance once a year, and if abnormal performance is observed.
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All modifications and repairs must be exclusively performed by brain4care.
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When disinfecting the sensor pin be careful to not apply excessive force.
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If the device functionalities are lost due to EM disturbances, the waveform may not be accurate.
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Ensure that your mobile device is set up with a strong password, not used in root mode, nor with unverified applications installed.
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Never share your password and user ID with others or write down your password in an easily accessible place.
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The account manager user profile is the most important one in the licensed portal when considering aspects of information security. It should be restricted to a few people in an organization, usually someone on the clinical engineering or information technology team.
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Before you assign or revoke a user access profile, make sure that the implications of this action are well understood and aligned with your organization. Brain4care is not responsible for any wrong assignment or revoke.
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The use of the B4C wireless sensor adjacent to or stacked with other equipment should be avoided. If such use is necessary, the device and the other equipment should be observed to verify that they are operating normally
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Only original charging cables and accessories shipped with the B4C System should be used. Do not use them in any other equipment or device. The use of accessories other than those specified may result in increased emissions or decreased immunity of the device.
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The B4C System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the B4C System helps to prevent electromagnetic interference by maintaining a minimum distance of 30cm (12 inches) between portable or mobile RF communication equipment (transmitters) and the B4C System.
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