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ATTENTION - make sure the steps below have been completed:
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Step 1 - start monitoring session
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 log into app and pairing sensor. |
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Step 2 - fill in patient data (optional)
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 monitoringpositioning” (1) as shown in Figure 6.6-2below.
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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 - For instructions on how to position the sensor and verify the waveform technical quality please read 6.5 positioning sensor and verifying signal6 position sensor |
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Step 4 - monitor patient
Once monitoring has started, a screen is shown in the mobile app, as shown in Figure 6.6-6the figure below, 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 5 position patient |
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PRECAUTION - The patient position or movement and the BcSs-PICNIW-1000 | BcSs-PICNIW-2000 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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Monitoring screen features
No. | Function | Description | |||
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1 | Back | End monitoringEdit patient info | Access to patient information screen for visualization and edit | ||
2 | See morphology tab | Directs to signal live waveform 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 tab that shows the full or partial monitoring session waveform stream |
4 | P2P1 tab | tab that shows minute by minute derived parameter of estimated P2P1 ratio (please refer to | |||
5 | UDI | Paired sensor identifierTTP tab | tab that shows minute by minute derived parameter of normalized time-to-peak (please refer to | ||
6 | UMI | Monitoring session identifierObservations | Opens the notes panel to add clinical notes to the monitoring session | ||
7 | Battery charge | Percentage level of internal battery (right) and external battery (left) | 8 Partial 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 | |
8 | external | External battery charge level in % (only relevant to BcSs-PICNIW-1000 sensor model) | |||
9 | Bluetooth signal strength | Bluetooth signal strength status. Green (good), yellow (regular) and red (bad) 9 | |||
10 | internal | Internal battery charge level in % | |||
11 | UDI | Sensor’s Unique ID number | |||
12 | Monitoring time | Time elapsed since start of monitoring session | |||
1013 | UMI | Unique Monitoring Session ID | |||
14 | End monitoring | End monitoring session button | |||
1115 | 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 | |||
Pause monitoring | Pause monitoring session button |
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)
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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. |
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.
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ICP
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waveform
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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.
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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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Step 6 - finalize monitoring session
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