The B4C System should be installed by a trained user, as such it is exempt from the checklist for warranty purposes.
5.1 mobile app installation
The brain4care app can be downloaded and installed from the Google Play Store or Apple App Store by following these steps:
Android (Google) | iOS (Apple) |
Step 1 - app store: On your mobile device, open the app store for your operating system (iOS or Android). | |
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Step 2 - Search for the app: Tap the search bar and enter "brain4care" to find the app. | |
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Step 3 - app selection: Select the brain4care app from the search results. | |
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Step 4 - installation: On the next screen, click INSTALL or GET. | |
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Step 5 - Open the app: After downloading and installing the app, click OPEN. | |
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CAUTION - Make sure your mobile device is configured with a strong password; do not use it in root mode, nor with unverified apps installed | |
Step 6 - GPS permission: To ensure proper functioning of the B4C System, you must enable location access for the device. | |
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Step 7 - make sure Bluetooth is active: To use the brain4care system, ensure Bluetooth is turned on. If it’s not, enable it in your device settings. | |
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Step 8 - corporate access account: To use the brain4care app, you must have a brain4care account. | |
Your corporate account manager must create and enable your user account for the application and system. For details, consult technical support or refer to the Portal Manual. ATTENTION - The device must not be set to power saving mode as this may affect the performance and functionality of the mobile device and mobile app. | |
5.2 location for operation
ATTENTION - It is recommended to keep the original packaging in case the equipment needs to be transported. Misuse of the product will void the warranty.
When selecting a location for using the B4C System, consider the following:
Operating Temperature: Ensure it is within the recommended range.
Brightness: Choose an area with appropriate lighting.
Power Outlets: Ensure availability if using a multiparameter monitor that requires power.
Space: Allow sufficient room for both professionals and patients to move.
The system should be used in a climate-controlled environment, with temperature, humidity, and pressure within the specifications outlined in section https://brain4care.atlassian.net/wiki/spaces/B4CSENSORGUIDE30/pages/3220244556/4+technical+characteristics#4.2-environmental
For transportation or storage of the equipment, ensure environmental conditions remain within the temperature, humidity, and pressure tolerance ranges specified in section https://brain4care.atlassian.net/wiki/spaces/B4CSENSORGUIDE30/pages/3220244556/4+technical+characteristics#4.2-environmental.
The equipment must be installed and used in an electromagnetic environment as described in annex 3 - electromagnetic safety standards.
Portable and mobile RF communication equipment may impact the product. Maintain a distance as specified in annex 3 - electromagnetic safety standards.
In coastal cities, salt spray can cause damage. Install equipment like air conditioners and dehumidifiers to maintain optimal conditions.
Ensure the equipment, particularly the sensors, is not exposed to direct sunlight.
For accurate monitoring, the patient should remain still during the session.
Avoid wetting the sensor or allowing it to come into contact with chemicals or flammable substances that could cause damage.
WARNING - Do not leave the equipment near flammable chemicals such as alcohol, benzene, etc. Should they come in contact with electrical parts, this may result in fire or internal short circuit. The same is true with the use of some flammable disinfectants.
5.3 power supply
The BcSs-PICNIW-2000 sensor features a single internal battery and is charged via an inductive charger. The sensor cannot be used while charging.
The BcSs-PICNIW-1000 sensor operates with two lithium-ion batteries: one internal and one external removable battery. The internal battery provides sufficient power to keep the sensor operational while the external battery is being charged separately.
For charging instructions please go to 6.11 charging sensor battery section.
ATTENTION - At no time should the sensor be connected to an external power supply.
WARNING - If the equipment is not be used for a long period of time, the external battery should be removed.
5.4 patient environment compatibility
The patient environment is where diagnostics, monitoring, or treatments occur, involving potential contact between the patient and parts of electromedical equipment or systems, or between the patient and individuals handling the equipment.
The BcSs-PICNIW-2000 sensor, BcSs-PICNIW-1000 sensor, external battery (BcAc-BATEX-1000), headbands kit (BcAc-AF-1000), and receiver module (BcAc-DG-1000) are designed for safe use in this environment.
Please refer to 12 technical documentation and annex 3 - electromagnetic safety standards.