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3.4.0 System components

The components that comprise a B4C System licence agreement are:

  • Sensor (model: BcSs-PICNIW-1000 or BcSs-PICNIW-2000);

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

  • brain4care mobile app, iOS or Android;

  • Sensor battery charger; (accessory);

  • Sensor user guide;

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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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.

2

1 BcSs-PICNIW-2000 sensor

module

kit

The sensor module

BcSs-PICNIW-2000

has exactly the same applications and functionalities as the

sensor

The BcSs-PICNIW-

1000 model but in a lighter format, with

2000 sensor features an intuitive visual interface, ergonomic design, and integrated

with the fixation tape

headband. The sensor

module has only one

includes a single internal battery and

features

supports inductive charging

with an approximate autonomy of

and provides up to 10 hours of continuous monitoring.

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BcSs-PICNIW-2000 sensor heaband

The BcSs-PICNIW-2000 sensor

module.3.4.3

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).

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BcSs-PICNIW-2000 sensor charger

The charger for the BcSs-PICNIW-2000 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.

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3.4.2 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.

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BcSs-PICNIW-1000 sensor

module.

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.

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

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).

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BcSs-PICNIW-2000 Sensor headband

For sensor BcSs-PICNIW-1000, there are 2 headband models:

headband kit

One Size Fits All HeadbandKit

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.

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Sensor single size headband

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

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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.

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Sensor headband

Tip

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

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.

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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.

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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)

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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 ).

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