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3.4.0 System components
The items that make up the system are listed below:
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components that comprise a B4C System licence agreement are:
Sensor (model: BcSs-PICNIW-1000 or BcSs-PICNIW-2000)
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;
Receiver (model: BcAc-
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DG-1000)
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Turnbuckle
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XXS, XS, S, M, L, XL and XXL Headband set
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Battery chargers (models BcAc-DCK-1000 or BcAc-DCK-2000)
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Charging cable
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AC adapter
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brain4care App (iOS or Android versions)
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brain4care Portal (https://portal.brain4.care)
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Optional dongle to connect to patient monitor (model BcAc-DG-1000)
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(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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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.
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3.4.2
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BcSs-PICNIW-2000 sensor module
The sensor module 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.
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Figure BcSs-PICNIW-2000 sensor module.
3.4.3 BcSs-PICNIW-
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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.
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BcSs-PICNIW-1000 sensor module.
3.4.4 BcAc-DG-1000 receiver module
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For any questions regarding monitor compatibility, contact our technical support team (item 9 technical support ).
3.4.5 Headband
The headband is used to position the sensor on the patient’s head. It consists of a turnbuckle and several band sizes or a single size headband. In addition to positioning the sensor on the correct lace on the patient head, this accessory is intended to transmit all perimeter cranial expansion to the sensor.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 versions of headband models:
Headband kit | One Size Fits All Headband | Headband kit |
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Version with two adjustable straps, where each has a snap button adjustment for three sizes.   Sensor single size headband | Version composed of 8 bands straps to adjust head circumference sizes, ranging from small to XL.    Figure 3.4.5-1 Sensor headband Version with fewer bands, where each band has a snap button adjustment for three sizes.  Figure 3.4.5-2 Sensor single size headband |
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TIP - Most - For BcSs-PICNIW-1000 most adults will need an M or L headband size. |
For sensor BcSs-PICNIW-2000, unlike the version BcSs-PICNIW-2000, it features an integrated turnbuckle with a strap and has a coarse perimeter adjustment containing two adjustments on each side. The head circumference covered by it caters to both small heads (42 to 55 cm) and larger heads (50 to 63 cm).
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Figure 3.4.5-2 Sensor headband
3.4.6 Battery charger
The charger supplies power to for the sensor BcSs-PICNIW-1000 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.
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The charger of BcSs-PICNIW-2000 sensor is a device designed to wirelessly and inductively charge the sensor directly. To do this, simply place 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 illuminate, indicating indicate that the sensor is being charged.
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Figure 3.4.6-2 Charger of sensor BcSs-PICNIW-2000
The charger for the BcSs-PICNIW-1000 sensor follow the respective design of charging an external battery. It enables the external battery to be charged while the sensor’s internal battery is being used to allow for 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.
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3.4.6 brain4care app
The brain4care app can be used on tablets or mobile phones running any mobile device compliant with:
Android 7.0 or higher with a minimum of 3 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 The mobile App connects to the supplied sensors (BcSs-PICNIW-1000 orvBcSsor BcSs-PICNIW-1000) and optionally also to the BcAc-DG-1000 receiver. The app It 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 generatedprocessed waveform information of derived parameters.
| Info |
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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. |
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