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The B4C System should be installed by a trained user, as such it is exempt from the checklist for warranty purposes.

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5.1 mobile app installation

Android (Google)

iOS (Apple)

Step 1 - App Store: Open the app store for your operating system (iOS or Android).

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Step 2 - Search for "brain4care" to find the app.

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Step 3 - Select the brain4care app from the search results.

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Step 4 - Install app (INSTALL for Android or GET for iOS).

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Step 5 - Open app after successful download and install

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Step 6 - Enable GPS for to enable location access.

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Step 7 - Activate Bluetooth to enable communication with sensors and dongle.

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Step 8 - Access corporate account to use mobile device

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.

Note

CAUTION - Make sure your mobile device is configured with a strong password; do not use it in root mode, nor with unverified apps installed

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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.

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5.2 location for operation

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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 the location for using the B4C System, consider the operating temperature, brightness, power outlets (if a multi parameter monitor that requires the use of a power outlet is used), and the space for movement of professionals and patients.

Location and Setup

  • Operating Temperature: Ensure it is within the recommended range.

  • Brightness: Choose a location with appropriate lighting.

  • Power Outlets: Ensure availability if using a multiparameter monitor that requires power.

  • Space: Allow enough room for both professionals and patients to move comfortably.

Environmental Conditions

  • Climate Control: The system should be used in a climate-controlled

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  • environment. Maintain temperature, humidity, and pressure within the

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  • Environmental.

  • Transportation and Storage: Ensure conditions remain within the specified temperature, humidity, and pressure

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Electromagnetic Compatibility

  • Installation Environment: Install and use the equipment in an electromagnetic environment

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  • as described in Electromagnetic Compatibility.

  • RF Communication Equipment: Maintain a distance from portable and mobile RF communication equipment

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In coastal cities, attention should be paid to the damage that can be caused by salt spray. It is recommended to install the necessary equipment (air conditioner and dehumidifier) to maintain the ideal conditions for the equipment.

Equipment (especially the sensors) must not be exposed to sunlight.

To facilitate monitoring, the patient should lie or sit still during a monitoring session.

Do not wet equipment nor come into contact with chemicals and / or flammables that could damage it.

Coastal Environment

  • Salt Spray: In coastal cities, use air conditioners and dehumidifiers to mitigate damage from salt spray.

Warning

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.

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5.

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3 power supply

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BcSs-PICNIW-2000 sensor

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Features a single internal battery and is charged via an inductive charger. It is not possible to use the product while the battery is being charged.The

The sensor cannot be used while charging.

BcSs-PICNIW-1000 sensor

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Operates with two lithium-ion batteries:

  • one internal

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  • one external removable battery.

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The internal battery provides sufficient power to keep the sensor running operational while the removable external battery is being charged , disconnected from the sensorseparately. For charging instructions please go to 6.11 charging sensor battery section.

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ATTENTION - At no time should the sensor be connected to an external power supply.

Warning

WARNING - If the equipment is not be used for a long period of time, the external battery should be removed.

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5.

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4 patient environment compatibility

The patient environment is the place where diagnostics, monitoring, or treatments occur and as such intentional and unintentional contact can occur between a PATIENT , involving potential contact between the patient and parts of Electromedical Equipment or Electromedical Systemelectromedical equipment or systems, or between a PATIENT and other people in contact with Electromedical Equipment of Electromedical Systemthe patient and individuals handling the equipment.

The wireless sensor BcSs-PICNIW-10002000 sensor, sensor BcSs-PICNIW-20001000 sensor, its external battery (BcAc-BATEX-1000), headbands kit (BcAc-AF-1000), and receiver module (BcAc-DG-1000) are adequate designed for safe use in this environment.

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5.4 mobile app installation

The brain4care app can be downloaded and installed from the Google Play Store or Apple App Store through the following steps:

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Android (Google)

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iOS (Apple)

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Step 1 - app store: On your mobile device click on the app store for the respective operating system, iOS or Android.

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Step 2 - Search for the app: Click on the search bar and search for the brain4care app.

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Step 3 - app selection: Click on the brain4care app that will appear in the list.

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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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Note

CAUTION - Make sure your mobile device is configured with a strong password; do not use it in root mode, nor with unverified apps installed

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Step 6 - GPS permission: For the correct functioning of the B4C System, it is necessary to allow device location access

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Step 7 - make sure Bluetooth is active: To use the brain4care system, make sure that Bluetooth is turned on, if not, turn it on in the 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 to use the application and system. For details, consult technical support or refer to the Portal Manual.

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Please refer to 12 technical documentation and annex 3 - electromagnetic safety standards.

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