4 technical characteristics

4.1 general characteristics

Table 4.1-1 Sensor Technical Specifications

² Estimated average power considering the fully charged internal battery and average component consumption. Maximum power considered with the internal battery fully discharged.

Table 4.1-2 Receiver technical characteristics

³ Estimated average and maximum power considering the monitor’s 5 V supply voltage.

4.2 environmental

4.3 connectivity

The wireless system uses radio frequency services to perform its functionalities. A brief description of the functionalities performed by the system and the Radio Frequency services required are summarized in the table below.

Table 4.3-1 Wireless Functionalities

Table 4.3-2 Technical characteristics of sensor

Brain4care Wireless System uses Bluetooth Low Energy technology to communicate with the wireless sensor, receiver and mobile device with brain4care application.

The Bluetooth connection in the wireless sensor and receiver has the following specifications:

The wireless Quality of Service is continuously monitored by B4C app in order to guarantee the required communication performance. If a minimum quality is not achieved, data loss may occur during transmission and the user is warned in the app. If it occurs, bring the sensor closer to the mobile device and check if the minimum quality has been achieved. Also, verify the existence of other wireless devices in the same room and check if the recommended separation distances described at Table 3-3 are maintained. In the event of lost network connection, user interaction may be required to reconnect. In accordance with AAMI TIR69 Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems, the B4C System was not required to undergo wireless coexistence testing.

The B4C application requires internet connection to login, send patient monitoring sessions data to the cloud and to receive the ICP reports. Any technology available on the mobile device that can provide internet connection (typically wifi 802.11 or LTE network) can be used. It is recommended that the mobile device should be used only in secured and encrypted networks.

4.4 batteries

4.4.1 Internal Battery

The sensor has an internal Li-Ion, 3.7 Vdc, 240mAh battery, with a recharge time of approximately three hours and a discharge of approximately five hours, allowing the external battery to be charged alone and without pausing monitoring.

Do not expose the sensor to heat sources. Excessive temperature can cause leaks and excessive heat can cause physical injury.

Table 4.4-1 Internal battery technical characteristics

4.4.2 external battery

The sensor is powered by a removable external battery, which is also responsible for recharging the internal battery. Battery composition is Li-Ion, 3.7 Vdc, 1000mAh. The sensor allows for patient transport both inside and outside the hospital.

Do not expose the sensor to heat sources. Excessive temperature can cause leaks and excessive heat can cause physical injury.

Table 4.4-2 External battery technical characteristics

4.5 external battery charger

The B4C external battery charger has the following characteristics:
Table 4.5-1 - External battery charger settings