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Step 1 - start 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 log into app.


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 positioning” as shown below.

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.

image-20240221-182258.png

TIP - if activated for your corporate account you can tag your monitoring session reports. Please refer to 6.6.2 tag monitoring sessions (optional)


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 6.6 position sensor


Step 4 - monitor patient

Once monitoring has started, a screen is shown in the mobile app, as shown in the figure below, where some information is presented to aid monitoring.

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 6.5 position patient

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.

image-20240221-182849.png

Monitoring screen features

No.

Function 

Description

1

Edit patient info

Access to patient information screen for visualization and edit

2

morphology tab

live waveform screen showing last 5 seconds of monitoring session

3

trend tab

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

TTP tab

tab that shows minute by minute derived parameter of normalized time-to-peak (please refer to

6

Observations

Opens the notes panel to add clinical notes to the monitoring session

7

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)

10

internal

Internal battery charge level in %

11

UDI

Sensor’s Unique ID number

12

Monitoring time

Time elapsed since start of monitoring session

13

UMI

Unique Monitoring Session ID

14

End monitoring

End monitoring session button

15

Pause monitoring

Pause monitoring session button

To end the monitoring session click on end monitoring. A popup window will appear asking you to confirm the end of the monitoring session. Click on save.

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.

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