3.4.0 system components
The items that make up the system are listed below:
Sensor module model BcSs-PICNIW-1000
External battery model BcAc-BATEX-1000
Turnbuckle
XXS, XS, S, M, L, XL and XXL Headband set
External battery charger
Charging cable
Power source for charging cable
brain4care App (iOS or Android versions)
brain4care Portal (https://portal.brain4.care)
Optional dongle to connect to patient monitor
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 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.
3.4.2 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 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.
3.4.3 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).
3.4.4 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.
TIP - Most adults will need an M or L headband size.
3.4.5 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.
3.4.6 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.
iOS 15 or higher with a minimum A12 processor 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.
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/B4CGUIDEAPP/pages/2390689754/5+equipment+installation#5.0-mobile-app-installation
Android (Google) | iOS (Apple) |
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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.