Release date: November 12 2021
This user manual is developed for clinicians who are responsible for remote monitoring of patients using the Levvel.connect.
The user manual has been written in a way that is thorough and understandable. In addition to this manual, user training is provided. All clinicians must either read this entire user manual or take the training provided before using Levvel.connect.
Levvel.connect is a software platform for Remote Patient monitoring. It consists of two integrated parts:
The clinician portal, a web application
Patient interface, a mobile device application
Through the mobile device application, patients can enter and follow their health data, and answer questions on their well-being. The clinician portal enables the healthcare team to monitor patients’ vital signs and follow disease development.
This combination of objective data and subjective responses enables the healthcare team to make informed, timely care decisions for better outcomes.
Levvel.connect is an informational tool only. It is not to be used as a substitute for professional judgement of healthcare providers in diagnosing and treating patients.
Levvel.connect is indicated for use by patients and by healthcare professionals for collection and review of data from patients who are capable and willing to engage in the use of Remote Patient Monitoring.
The flexibility of the system allows the healthcare team to design and distribute individual or generic electronic questionnaires. It is furthermore possible to add threshold values for reference when reviewing reported data in the web application.
The Levvel.connect software must be configured by clinical users in order to be utilised to collect data as described above. The software does not in itself provide any protocols or procedures to obtain data from patients.
Levvel.connect does not provide any real time alerts and is not intended to provide automated treatment decisions or diagnosis.
When logging in, the Overview page shows patients who have been assigned to you and who have pending alarms. Menu and general navigation features are described below:
Administrator Menu When you click on the “Administrator Menu” button at the top right, you will be taken to the Administrator menu. Here you see the submenus that are important for system administrators.
Select the "Show due date" check box, if applicable. If this is checked, the gestational age is calculated and displayed at the top of the patient menu.
Press "Create" to create the patient group.
Click on "Next"
Select / click on the desired patient group or groups. It is possible to link more than one patient group to a patient by pressing the "ctrl" key when selecting patient groups.
Click "Next". (Pay attention to the navigation settings: "Back" to return to the previous page, "Save" and "Save + Go to monitoring plan".)
Enter / Create patient threshold values. Threshold values are inherited from the patient group or groups associated with the patient.
Views for which patient app logging is currently enabled. App logging is enabled until the date in "Active until"
Info and guidance are used to provide easy access to public health information for patients in a particular patient group.
Create a new link for info and instructions:
Click on "Info and instructions for" in the administrator menu.
Click "Create links" to create info or instructions.
Enter the name of the category for info or guidance.
Enter the description of the specific link.
Enter or copy the link to the web you want to add to the category.
or Press the "Upload" button to upload a file and link to the uploaded file.
Press the "+" button to add the link to the category.
Select the patient group.
Press or to edit or delete the link.
Enter a new description and a link for an info or guide as described above.
Click "Create" to create the link and return to the Info and Guide list.
For continuous CTGs, the patient selects which setting of uterine activity sensitivity to use on the Monica AN24 device (see the user documentation for the AN24 device for the correct setting for use).
Once recording has been started by the patient, a "Continuous CTG" column will appear below the "Completed Questionnaires" view below that patient. "Continuous CTG" cell shows which sensitivity setting the patient has selected.
Normally, the measurement continues until the patient stops it, but there may be circumstances where the system actively stops the measurement.
This can occur in two circumstances:
Slow network connection (or no connection) between the patient tablet and the server means that data delivery cannot keep up with measurement data.
Slow network connection (or no connection) between the server and the remote CTG viewer means that data delivery cannot keep up with measurement data. In either case, there is some leeway to prevent intermittent network problems from preventing a measurement from being performed. In both cases, the patient will be informed that the measurement has stopped due to network problems.
Questionnaire-based CTGCTG Questionnaire-based is collected
Once the patient has completed the questionnaire, it becomes visible in the "Completed Questionnaires" view. The measurement is transferred to an external viewer. You can see the possible status of the transfer below:
The information in this document is subject to change without notice.
Levvel Health ApS
Savsvinget 7, 2970 Hørsholm
The supplier is only responsible for the software itself.