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3.4.0
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System components
The items that make up the system are listed below:
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Sensor module model modules (models BcSs-PICNIW-1000 or BcSs-PICNIW-2000)
External battery for sensor BcSs-PICNIW-1000 (model BcAc-BATEX-1000)
Turnbuckle
XXS, XS, S, M, L, XL and XXL Headband setExternal
battery chargerBattery chargers (models BcAc-DCK-1000 or BcAc-DCK-2000)
Charging cablePower source for charging cable
AC adapter
brain4care App (iOS or Android versions)
brain4care Portal (https://portal.brain4.care)
Optional dongle to connect to patient monitor (model BcAc-DG-1000)
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3.4.1
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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 sensor 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
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BcSs-
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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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Figure 3.4.2 BcSs-PICNIW-1000 sensor module.
3.4.3 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 3.4.3
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BcSs-PICNIW-2000 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 (item 9).
3.4.
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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.
For sensor BcSs-PICNIW-1000, there are 2 versions of headband:
Headband kit | One Size Fits All Headband |
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Version composed of 8 bands to adjust head circumference sizes, ranging from small to XL.    Figure 3.4.5-6a 1 Sensor headband | Version with fewer bands, where each band has a snap button adjustment for three sizes.   Figure 3.4.5-6b 2 Sensor single size headband |
| Tip |
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TIP - 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
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-2 Sensor headband
3.4.6 Battery charger
The charger supplies power to the sensor’s 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 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 that the sensor is being charged.
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Figure 3.4.6-2 Charger of sensor BcSs-PICNIW-2000
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 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 sensors (BcSs-PICNIW-1000 orvBcSs-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.
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