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ATTENTION - make sure the steps below have been completed:
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From the main screen click on new session (1) button to start monitoring session.
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TIP - For login instructions and pairing sensor please read section 6.3 loging into app and pairing sensor. |
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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
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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. |
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Categorize session with tags (optional)
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ATTENTION - report classification via tags must be activated by your organization before you can use it. |
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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.
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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. |
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TIP - You can add classification tags in all patient information forms that are available at the start, middle and end of a monitoring session. |
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Once satisfied with the pulse morphology displayed on the app’s sensor positioning screen Figure 6.6-5, click the start monitoring button (1).
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ATTENTION - For instructions on how to position the sensor and verify the waveform technical quality please read 6.5 positioning sensor and verifying signal |
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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.
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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 |
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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. |
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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.
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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. |
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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.
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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. |
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WARNING - The B4C System has not been validated to be a substitute for invasive ICP monitoring methods in any cases. |
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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. |
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WARNING - The appearance of a normal waveform morphology does the eliminate the possibility of elevated intracranial pressure or irregularity in brain compliance. |
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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 |
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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.
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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. |
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