3.5 components that come with the product

The items that make up the system are listed below:

• Sensor module model BcSs-PICNIW-1000

• External battery model BcAc-BATEX-1000

• Receiver module model BcAc-DG-1000 (if acquired)

• XXS, XS, S, M, L, XL and XXL Headband set

• External battery charger

• Brain4care mobile application and access to brain4care portal (please refer to portal user guide)

• Sensor user guide

3.5.1 system description

A summary of operation of the components that make up the system is shown in Figure 3.5-1.

The BcSs-PICNIW-1000 sensor 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.

3.5.2 bcss-picniw-1000 sensor module

The BcSs-PICNIW-1000 sensor module monitors intracranial pressure by measuring the cranial casing volumetric variation. The monitoring process is performed by positioning the sensor in the patient’s head, and the information is sent using Bluetooth wireless technology, to the other modules. The sensor is powered by a rechargeable external battery which together with the internal battery allows for 24 hours of continuous monitoring autonomy.

3.5.3 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.

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

3.5.4 headband

The headband is used to position the sensor on the patient’s head. It consists of a turnbuckle and several band sizes. In addition to positioning, this accessory is intended to transmit all perimeter cranial expansion to the sensor.

3.5.5 external battery charger

The charger supplies power to the sensor’s removable external battery. It is a device designed to enable the external battery to be charged in a timely manner before the sensor’s internal battery discharges, ensuring continuous use of the sensor.

With magnetic connectors on the sides, the charger is capable of connecting two other chargers, allowing for up to three simultaneous battery charging.

3.5.6 brain4care app

The brain4care app can be used on tablets or mobile phones running Android 7.0 or higher with a minimum of 2 GB of RAM and Bluetooth® 4.2 or 5.0. It is intended to connect with the BcSs-PICNIW-1000 sensor and the BcAc-DG-1000 receiver. The app allows for real-time visualization of the sensor waveform and trend, that along with patient data, are sent to the cloud system where a monitoring report is processed and generated.

The app can be downloaded and installed from the Google Play Store using the steps below:

Step 1. On an Android mobile device, open the Google Play Store (1).

Step 2. Click on the top search bar (1).

Step 3. Type brain4care.

Step 4. Then click on the search button on the keyboard.

Step 5. Then, click on the brain4care app that will appear in the list.

Step 6. On the next page, click INSTALL.

Step 7. After the application is downloaded and installed, click OPEN.

Step 8. For the correct operation of the application, it is necessary to allow access to device location and files (1).

Step 9. Whenever using the brain4care system, make sure Bluetooth(1) is enabled, if not, enable it in your device settings (see Figure 3.5-6).

Figure 3.5-6 Mobile device connection setup screen

Step 10. To use the brain4care application it is necessary to have a brain4care account. Your corporate account manager must activate your user to allow usage of the application and system. For details, see technical support or refer to the /wiki/spaces/B4CDOC/pages/1812463629.