6.5 monitoring with the app.

To use the mobile device, you must have the brain4care app installed. If you have not already done so, see section 3.5.6.

Step 1. Open the brain4care app by clicking on the marked icon (1).

Open

Figure 6.5-1 Opening the application.

Step 2. On the home screen, log in by selecting the document type (ID (for US) or CPF (for Brazil))(1),

followed by the ID or CPF(1) and password(2), and press login (4).

Open

Figura 6.5-2 Login into the app

Step 3. Select the organization (corporate account)(1) for the organizations with open lock(2) mean that you already used the organization password in step 2, if the lock is closed (3), it will be necessary to go through step 4.

Step 4. Then enter the password(1) and click LOGIN. If the organization you want does not appear, reach out to your clinical engineering team to request access.

Step 5. To start pairing, make sure the sensor is turned on. Then in the app, Click the sensor button(1). The search function will then start for sensors that are connected and pairable.

Step 6. A list of turned-on sensors, that are at close range, will appear on your mobile app screen(1). To pair with the desired sensor, check the sensor UDI (unique device id) on the sensor opposite to the on/off buttons, and then select it on the mobile app list. Some sensors may not be available for selection (greyed out) as they are not activated, locked, do not belong to your organization, or are awaiting activation (if your sensor is grayed out, check with your clinical engineering team).

Step 7. After selecting the sensor, a visual confirmation for pairing with the desired device will begin. The actual sensor and the sensor image in the mobile application will emit a light signal with the same color and flashing frequency. If this pattern is the same between the mobile app and sensor, the chosen sensor is the correct one, click “Confirm” to continue pairing. If the pattern does not match or you want to change sensors, click on the “Reselect” button.

Once the chosen sensor is confirmed, the status LED will flash green three times and a success pop-up window will appear in the mobile application. To proceed, click on “Start monitoring”(1). Alternatively, the “Pair Receiver”(2) button is for sensor pairing with a receiver which allows viewing the sensor waveform on a compatible multiparameter patient monitor (this pairing method will be explained in section 6.6 - MONITORING WITH A MULTIPARAMETER MONITOR).

Step 8. After pairing, you must identify the patient that will be monitored. This information will be used and recorded in the final waveform report. Fill in all data correctly and then click on “Start monitoring”(1).

For quicker monitoring, you can choose to skip this step, but for the waveform report to be generated, you must fill in the patient information at the end of the monitoring session (see below).

Step 9. Prior to starting and recording a monitoring session, you will be directed to the sensor positioning screen, where you can see if the sensor has been properly tightened. The “Start Monitoring”(1) button will only turn green when tightening is adequate.

To avoid errors in signal analysis and report generation, it is important to verify if the sensor waveform is of good quality and the Bluetooth signal level is at a minimum level. Please refer to figure 6.7-3 in section 6.7 examples of ICP waveforms in most common situations.

If correctly positioned, the waveform shown on the positioning screen should have a typical ICP waveform characteristic. Such familiarity with the waveform shape is a clinician's decision based on his experience and exposure to ICP waveforms. If needed the sensor can be re-positioned and/or tightened by slightly turning the turnbuckle clockwise and counterclockwise respectively. The sensor should be neither too tight nor loose(1).

Proper tightening does not guarantee that the signal will be of good quality; The sensor position in the head also influences the signal quality. So if the tightening does not resolve, loosen the headband by turning the turnbuckle counterclockwise and try to reposition the sensor by varying the tightness and position until an ICP familiar waveform signal appears.

Step 10. Once monitoring has started, a screen is shown in the mobile application, as shown in Figure 6.5-11, where some information is presented to aid monitoring. Table 6.5-1 describes the functionality of each screen field.

Important: It is recommended for good monitoring session quality that the patient be kept at rest and as still as possible. Please refer to Section 6.7.1. Sensor Placement Instructions for detailed instructions

Table 6.5-1 Monitoring screen features

To end the monitoring session click on “End Monitoring” (Item 10 of Figure 6.5-11). A popup will appear asking you to confirm the end of the monitoring session. Click on “Save”.

Step 11. Once the monitoring is complete you will be directed to the result screen. Here you can fill in or edit patient data on the same screen before the final report is generated. You can also access a partial report by clicking on the expand/zoom button on the right side.

Once the information is confirmed, you can click “Confirm”(1) which will submit the data to the brain4care portal and allow you to view the report in the mobile app, or you can click “Postpone”(2) and then submit the data in the future.

Step 12. If you choose to save, the final data will be sent to the brain4care cloud, which will process and download the final report.

While the final report is processing you will still have real-time access to the most updated report.

Once the final report is available the status will be updated as Complete.

You can also export the report in PDF format. Click on the Export PDF as shown in figure Figure 6.5-13.

A PDF file of the final report is then saved to your local mobile device. When Clicking on “Open” the mobile device will ask you to use an installed application to read the PDF file. Select the application you typically use to view the report.