ATTENTION - make sure the steps below have been completed:
installed app (https://brain4care.atlassian.net/wiki/spaces/B4CSENSORGUIDE29/pages/2853210148/5+equipment+installation#5.0-mobile-app-installation)
sterilized sensor (6.1 disinfecting the sensor)
sensor assembled with headband (6.2 choosing headband and assembling sensor)
app login and sensor paired (6.3 loging into app and pairing sensor)
sensor positioned signal checked (6.5 positioning sensor and verifying signal)
Step 1 - trigger monitoring session
From the main screen click on new session (1) button to start monitoring session.
TIP - For login instructions and pairing sensor please read section 6.3 loging into app and pairing sensor.
Step 2 - fill in patient data
At the beginning of the monitoring session, an optional step is to fill patient data. This information will be used and recorded in the final report. Fill in all data correctly and click on “start monitoring”(1) as shown in Figure 6.6-2
TIP - For faster monitoring, you can choose to skip this step, but for the report to be generated, you will have to fill in the patient information at the end of the monitoring session.
Categorize session with tags (optional)
ATTENTION - report classification via tags must be activated by your organization before you can use it.
If activated, you can classify your monitoring session with predefined tags to facilitate report filtering in the report listing screen.
Click on the report category 
button.
A popup window will appear with the available classification tags your organization made available in advance. Choose one or more tags to classify the monitoring session.
ATTENTION - Classification tags are defined centrally by your organization such as available tags as well as minimum to maximum amount of required and allowed tags respectively.
TIP - You can add classification tags in all patient information forms that are available at the start, middle and end of a monitoring session.
Step 3 - initiate monitoring
Once satisfied with the pulse morphology displayed on the app’s sensor positioning screen Figure 6.6-5, click the start monitoring button (1).
ATTENTION - For instructions on how to position the sensor and verify the waveform technical quality please read 6.5 positioning sensor and verifying signal
Step 4 - monitor patient
Once monitoring has started, a screen is shown in the mobile app, as shown in Figure 6.6-6, where some information is presented to aid monitoring. Table 6.6-1 describes each screen field.
ATTENTION - It is recommended for good monitoring session quality that the patient be kept at rest and as still as possible. Please refer to Section 6.4 positioning the patient
PRECAUTION - The patient position or movement 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.
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 form 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 6.6-6). A popup window will appear asking you to confirm the end of the monitoring session. Click on save.
Step 5 - interpret the surrogate ICP waveform
A satisfactory waveform reading may present any of the typical ICP shape characteristics below (Figure 6.6-3) according to the patient’s clinical condition (from normal to pathological)
As a suggestive reference, the waveforms below (Figure 6.6-8.A to 6.6-8.G) are non invasive ICP waveforms that can be shown with the noninvasive ICP sensor.
WARNING - The appearance of a normal waveform morphology does not eliminate the possibility of elevated intracranial pressure or irregularity in brain compliance.
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ATTENTION - The waveforms above are examples of typical noninvasive ICP waveforms in different clinical settings. You may see variations in the ICP waveform, but they should always follow a similar pattern.
The monitoring session should be as long as required to assess the ICP waveform. Typical sessions are of 15+ minutes but the final duration is ultimately defined by a trained professional. The session should be finalized upon patient request due to discomfort or decision by the primary caregiver.
The ICP pulse waveform (Figure 6.6-9) is an alternative to assess certain ICP characteristics, irrespective of the absolute values that are typically captured by an invasive method .
The ICP waveform contains characteristics that can be mathematically analyzed such as:
Wave peaks: P1 (percussion wave, due to arterial pressure being transmitted from the choroid plexus to the brain ventricles), P2 (tidal wave, related to brain compliance) and P3 (dicrotic wave);
Absolute amplitude of wave peaks: dP1 (relative amplitude of percussion wave), dP2 (relative amplitude of tidal wave), dP3 (relative amplitude of dicrotic wave);
Absolute lags in milliseconds of wave peaks: LT (considered the initial timestamp of a pulse), L1 (lag for percussion wave), L2 (lag for tidal wave), L3 (lag for dicrotic wave), Lx (variable lag);
Absolute curvature of wave peaks: Curv1 (percussion wave curvature), Curv2 (tidal wave curvature), Curv3 (dicrotic wave curvature).
Under normal ICP conditions, the relative amplitudes of the three peaks are related as follows: P1 > P2 > P3 (Box A in Figure 6.6-4 above). In conditions with decreased brain compliance and rising ICP, the pulse waveform morphology gradually changes and certain indicators, such as the estimated P2/P1 ratio eventually increases.
WARNING - The BcSs-PICNIW-1000 Sensor does not replace a comprehensive clinical evaluation. The waveform output should always be evaluated by the clinician in conjunction with other clinical parameters or analyses.
WARNING - The B4C System has not been validated to be a substitute for invasive ICP monitoring methods in any cases.
WARNING - The medical professional is responsible for determining the additional clinical parameters or analyses required in addition to the BcSs-PICNIW-1000 Sensor waveform to make a clinically informed decision.
WARNING - The appearance of a normal waveform morphology does the eliminate the possibility of elevated intracranial pressure or irregularity in brain compliance.
WARNING - The clinician is reminded to assess the waveform morphology in real-time during a monitoring session. The B4C report is available for the clinician’s convenience to review associated waveform parameter estimates and other clinical observations entered in a past monitoring session
Step 6 - finalize monitoring session
Once the monitoring session is complete you will be directed to a confirmation screen. Here you can fill in or edit patient data 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 confirmed, you can click “Confirm”(1) which will submit the data to the B4C System 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 7 - final monitoring session report
If you choose to confirm the patient data, the next screen will be the monitoring report view. The screen elements are described bellow:
(nr.1) Report status:
PARTIAL = parts of the submitted data still needs to be processed.
FINAL = all monitored data has been processed.
(nr.2) Monitoring status:
IN PROGRESS = monitoring in progress, the report being viewed is an intermediate report.
ENDED = monitoring has ended.
(nr.3) Update button = is active when pending data has been processed and made available.
(nr.4) Option to export and open PDF
Export PDF - option to download the report in PDF format
Open PDF - option to open a downloaded PDF report
If you choose to open PDF, a file of the final report is saved on your local mobile device. When you click “Open”, the mobile device will prompt you to use an installed application to read the PDF file or ask for one if none have been installed. Select the application you normally use to view the report.
ATTENTION - Avoid downloading reports in PDF format on your mobile device. Please read section 6.7 b4c report for a detailed view on the B4C System’s report.
