To use the mobile device, you must have the brain4care app installed. If you have not already done so, see section 3.4.5.
Step 1. Open the brain4care app by clicking on the marked icon.
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”.
Figura 6.5-2 Login into the app
Step 3. Select the organization (corporate account) for which you are monitoring for.
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.
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.
Figure 6.5-5 Adding Sensor.
Step 6. A list of sensors 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 buttons, and then select it from the mobile app list. Some sensors may not be available for selection (greyed out) as they are inactive, locked, do not belong to your organization or are awaiting activation (if your sensor is grayed out, check with your clinical engineering team).
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.
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).
Figure 6.5-8 Pairing completed.
Step 8.Step 8. After pairing, you must register 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 emergency 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).
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.
ATTENTION - For detailed instructions on sensor placement and monitorization, please, refer to “assessing the braincare waveform” section 6.7.
To avoid errors in signal analysis and report generation, it is important to verify if the brain4care waveform is of good quality and the Bluetooth signal level is at a minimum level. Please refer to figure 6.7-3 examples of ICP waveforms in most common situations.
Figure 6.5-10 Positioning Screen.
If the signal shown on the positioning screen does not have a typical ICP waveform characteristic, then the sensor has not been properly positioned or tightened. If this happens, first check that the sensor is tightened correctly by looking at the information on the mobile application screen. The sensor should be neither too tight or loose. Try tightening or loosening the turnbuckle slightly by turning clockwise and counterclockwise respectively, and see if the signal quality ICP waveform improves.
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 the ICP waveform signal appears satisfactorily.
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
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.
Figure 6.5-11 Monitoring Screen.
Table 6.5-1 Monitoring screen features
No. | Function | Description |
|---|---|---|
1 | Back | End monitoring |
2 | See morphology tab | Directs to signal screen showing last 5 seconds of monitoring session |
3 | Edit patient data | Opens a panel for filling in and editing patient data, as well as including observations related to the monitoring session |
4 | See trend tab | Directs to trend screen that shows the full or partial monitoring session |
5 | UDI | Paired sensor identifier |
6 | UMI | Monitoring session identifier |
7 | Battery charge | Percentage level of internal battery (right) and external battery (left) |
8 | Bluetooth signal strength | Bluetooth signal strength status. Green (good), yellow (regular) and red (bad) |
9 | Monitoring time | Time elapsed since start of monitoring session |
10 | End monitoring | End monitoring session button |
11 | 01m Report | Partial report access button where the two digits before the “m” informs how many minutes of the monitoring session will be included in the report |
12 | Add Notes | Opens the observation add panel |
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, 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 in 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 “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.
Figure 6.5-12 Monitorization Confirmation Screen.
Step 12. If you choose to save and send data to the brain4care cloud, the application 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.
Figure 6.5-13 Opening the Report
Once the final report is available the status will be updated as Complete as shown in the image below.
You can also export a report in a PDF format. Click on the Export PDF as shown on figure Figure 6.5-13.
A PDF file of the final report is then saved to your local device. When Clicking on “Open” the mobile device will ask you to use an installed application to read the PDF. Select the application you typically use to view the report.