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Anchortoptopback to index | back to introduction

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Info

ATTENTION - It is recommended to keep the original packaging in case the equipment needs to be transported. Improper use of the product will void warranty.

3.4.

0 System components

The components that comprise a B4C System licence agreement are:

Sensor (model:

1 BcSs-PICNIW-

1000 or

2000 sensor kit

BcSs-PICNIW-2000

);

  • Receiver (model: BcAc-DG-1000) (optional);

  • brain4care mobile app, iOS or Android;

  • Sensor battery charger; (accessory);

  • Sensor user guide;

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    3.4.1 System description

    A summary of operation of the components that make up the system is shown in Figure 3.4-3.

    The sensor (BcSs-PICNIW-1000 or BcSs-PICNIW-2000) is placed on the patient with a headband that transmits the captured signal to the BcAc-DG-1000 receiver module and / or mobile device that has the brain4care app installed. The mobile application allows the visualization of monitoring reports processed in brain4care analytics.

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    3.4.2

    sensor

    The BcSs-PICNIW-2000 sensor features an intuitive visual interface, ergonomic design, and integrated headband. The sensor includes a single internal battery and supports inductive charging and provides up to 10 hours of continuous monitoring.

    image-20240206-205219.pngImage Added

    BcSs-PICNIW-2000 sensor heaband

    The BcSs-PICNIW-2000 sensor model features an integrated turnbuckle with a strap that offers two adjustments on each side for fine-tuning the fit. Two models are available to accommodate different head sizes: one for smaller heads (42 to 55 cm) and another for larger heads (50 to 63 cm).

    FINAL_simples-20230913-192153.jpgImage Added

    BcSs-PICNIW-2000 sensor

    module

    charger

    The sensor module charger for the BcSs-PICNIW-2000 has exactly the same applications and functionalities as the BcSs-PICNIW-1000 model but in a lighter format, with an intuitive visual interface, ergonomic design, and integrated with the fixation tape. The sensor module has only one internal battery and features inductive charging with an approximate autonomy of 10 hours of continuous monitoring.

    image-20240206-205219.pngImage Removed

    sensor is designed for wireless, inductive charging. To charge the sensor, place it on the charger with the logo and button facing upwards, then connect the charger to the AC adapter. When correctly positioned, the sensor light will illuminate, indicating that charging is in progress.

    Click here for charger technical specifications.

    image-20240206-210437.pngImage Added

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    3.4.

    3

    2 BcSs-PICNIW-1000 sensor kit

    BcSs-PICNIW-1000 sensor

    module

    The BcSs-PICNIW-1000 sensor module monitors intracranial pressure by measuring the cranial volumetric variation. The monitoring process is performed by positioning the sensor in the sensor is positioned on the patient’s head, and the information is sent using data is transmitted to other components via Bluetooth wireless technology to the other modules(mobile app and/or dongle). The sensor is powered by a rechargeable external battery , which together , along with the internal battery allows for , provides up to 24 hours of continuous monitoring autonomy.

    image-20240206-202805.png

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    3.4.4 BcAc-DG-1000 receiver module

    The BcAc-DG-1000 receiver module (dongle) enables the captured waveform reproduction on a multiparameter patient monitor. This transmission is done by pairing the sensor, which transmits data via Bluetooth, and the receiver, which transmits the same data by connecting to the monitor’s invasive pressure input. There are several versions of receivers, each with the connector adapted for a monitor model. Please see Appendix 2 for more options.

    image-20240823-151042.pngImage Removed

    For any questions regarding monitor compatibility, contact our technical support team (9 technical support ).

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    3.4.5 Headband

    The sensor BcSs-PICNIW-2000 features an integrated turnbuckle with a strap with two adjustments on each side for combined with a turnbuckle the fine adjustments. Two models are available to cover small heads (42 to 55 cm) and larger heads (50 to 63 cm).

    FINAL_simples-20230913-192153.jpgImage Removed
    For sensor BcSs-PICNIW-1000, there are 2 headband models:

    BcSs-PICNIW-1000 sensor headband kit

    One Size Fits All Headband Kit

    Single Sized Headband

    kitVersion with

    Kit

    This kit features two adjustable straps

    , where each has

    with a snap-on button that enables an initial broad adjustment

    for

    of three different sizes. An attached turnbuckle then allows for secondary fine adjustment for a snug fit.

    Image ModifiedImage Modified

    Sensor single size headband

    Version composed of 8 straps to adjust head circumference sizes, ranging from small to XL.

    Image RemovedImage Removed

    This kit features eight straps of prescribed lengths ranging from XXS to XXL. An attached turnbuckle then allows for secondary fine adjustment for a snug fit.

    Image AddedImage Added

    Sensor headband

    Tip

    TIP - For BcSs-PICNIW-1000 most adults will need an M or L headband size.

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    3.4

    .

    6 Battery charger

    The charger for the

    BcSs-PICNIW-

    2000 sensor is a device designed to wirelessly and inductively charge the sensor directly. Place the sensor with the logo and button facing upwards onto the charger and power it using the AC adapter. Upon correct positioning, the sensor light will indicate that the sensor is being charged.
    image-20240206-210437.pngImage Removed

    1000 sensor charger

    The charger for the BcSs-PICNIW-1000 sensor follow the respective design of charging is designed to charge an external battery. It enables , enabling continuous sensor use by charging the external battery to be charged while the sensor’s internal battery is being used to allow for continuous use of the sensorin operation.

    With Equipped with magnetic connectors on the sides, the charger is capable of connecting two other can be linked with two additional chargers, allowing for up to three simultaneous battery chargingbatteries to be charged simultaneously.

    image-20240823-150827.png

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    3.4.

    6 brain4care

    4 Mobile app

    The brain4care app can be used on any mobile device compliant with:

    Android

    app connects to the sensors and receiver (optional). It enables real-time visualization of the sensor waveform and cloud-processed waveform information, including derived parameters.

    Android (Google)

    iOS (Apple)

    Image AddedImage Added
    Info

    ATTENTION - Minimum mobile device requirements (ANNEX 3)

    • Android: Version 7.0 or higher, with a minimum of 3 GB of RAM and Bluetooth® 4.2 or 5.0.

    • iOS: Version 15 or higher, with a minimum A12 processor and Bluetooth® 4.2 or 5.0.

    The mobile App connects to the supplied sensors (BcSs-PICNIW-1000 or BcSs-PICNIW-1000) and optionally also to the back to top

    3.4.5 Receiver (optional)

    The BcAc-DG-1000 receiver

    . It allows for real-time visualization of the sensor waveform and cloud processed waveform information of derived parameters.
    Info

    ATTENTION - Use the brain4care mobile app only on tablets or mobile devices that meet the requirements defined in ANNEX 3 and comply with IEC 60601-1. The Bluetooth module of the mobile device must be FCC approved.

    The app can be downloaded and installed from the Google Play Store or Apple App Store. For installation instructions please refer to https://brain4care.atlassian.net/wiki/spaces/B4CSENSORGUIDE30/pages/3220244574/5+equipment+installation#5.0-mobile-app-installation

    Android (Google)

    iOS (Apple)

    • Google Play Store

    • Apple App Store

    Image RemovedImage Removed InfoATTENTION - It is recommended to keep the original packaging in case the equipment needs to be transported. Improper use of the product will void warranty.

    module (dongle) allows the captured waveform to be displayed on a multiparameter patient monitor. It receives data transmitted wirelessly from the sensor via Bluetooth and then relays this information to the monitor’s invasive pressure input. Different versions of the receiver are available, each designed to fit specific monitor models. For details on available options, please refer to Annex 2.

    For any questions regarding monitor compatibility, contact our technical support team (9 technical support ).

    image-20240823-151042.pngImage Added

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