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

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Figure 6.5-1 Opening the application.

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

followed by the number and password, and press “Enter”.

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Figura 6.5-2 Login into the app

Step 3. Select the organization (corporate account) for which you are monitoring for.

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Figure 6.5-3 Selecting the organization.

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

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Figure 6.5-4 Entering the organization password.

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

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Figure 6.5-5 Adding Sensor.

Step 6. A list of turned on sensors, that are at close range, will appear on your mobile app screen. 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).

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Figure 6.5-6 Choosing Sensor.

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.

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Figure 6.5-7 Confirming sensor pairing.

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”. Alternatively the “Pair Receiver” 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).

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Figure 6.5-8 Pairing completed.

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”.

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).

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Figure 6.5-9 Patient data registration screen.

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” button will only turn green when tightening is adequate.

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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.

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Figure 6.5-10 Positioning Screen.

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 clinicians decision based on his experience and exposure with 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 or loose.

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Note

PRECAUTION - The position, or movement, of the patient and the BcSs-PICNIW-1000 Sensor is known to affect the signal being recorded. As a result, if multiple recording sessions are obtained on the same patient, consistent positioning of the patient and device will lead to more comparable recordings.

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Figure 6.5-11 Monitoring Screen.

Table 6.5-1 Monitoring screen features

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Once the information is confirmed, you can click “Save” 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” and then submit the data in the future.

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Figure 6.5-12 Monitorization Confirmation Screen.

Step 12. If you choose to save, 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.

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Figure 6.5-13 Opening the Report

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

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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.

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