User Manual

System Administration
Version 1.1
Release date: November 12 2021
Introduction
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.
Intended use of Levvel.connect software
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.
Indication for Use
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.
Navigation
General Navigation
Log in to the system
Enter the URL you have received in your web browser or click on the link you have received. Enter your username and password.
The first time you log in, you will be asked to change your password. Click "Login"
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Note Your username and initial temporary password will be provided by the administrator. Passwords must be at least 8 alphanumeric characters in length and must contain 1 number. |
Change password and log out of the system
Click on "Profile" at the top right. Enter your current password, then enter your new password and repeat the password. Click "Update". When you are ready to log out of the system, click on "Log out" in the upper right corner.
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Tip The Clinician Portal is a web-based application and can be used anywhere as long as you have access to the internet. The website functions best with Google Chrome, Mozilla Firefox, or Microsoft Edge. |
Default login page
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:
The main menu provides access to the submenus: Overview, Calendar (Optional), Patient Group Messages (Optional), Find Patient, Create Patient, and All Notes for My Team Pages. The gear wheel displays the Administrator menu.
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Navigating the
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.
Manage the users of your system. Create patient groups and edit basic information. See a log page of all patient app activities. See a log page of all activities (users and patients).
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Note These submenus are only available from the Administrator menu. |
Profile Management
Users
Creating a new user
Click on "Users" in the Administrator menu. It is possible to search for a user by name or part of the name. Enter criteria and click on "Search". List of users already created. Click "Create User" Enter user information. Click on "Create".
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Tip To assign multiple roles or patient groups to a user, simply hold down the “ctrl” button. |
User roles Access for all patients: Provide access to see all patients in the system. Administrator: Access all administration menus. Clinician: Provide access to all clinician menus (those described in the clinician's user manual). Video Consultant: Provide access to video conferencing functionality that allows clinicians to call patients in the app.
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Click “Users” in the administrator menu. The list of users already created. Select the user you want to edit and double-click the name. The "View user" menu opens. Click on "Edit". Edit user or reset password.
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Note Users cannot be deleted once created. |
Create new user roles
Click on "User roles" in the administrator menu. Click on "Create". Name the user role. Assign user role rights Click "Create".
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Departments
Create and edit department
Click on "Departments" in the administrator menu. The list of departments already created in the system. Tap to edit / modify an existing department. Press "Create" to create a new department.
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Notes The "Wards" menu is used to create and manage the various wards Each ward may have one or more patient groups assigned. |
Managing Patients
Patient Groups
Creating a Patient Group
Click "Patient Groups" in the Admin Menu. List of patient groups already created Tap "Create patient group" to create a new patient group.
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Setting up a patient group
Enter the name of the new patient group. Choose which department the patient group is to be associated with. Select questionnaire group (s). Select the "Enable patient to/from patient" checkbox to enable the "Messages" menu for clinicians and patients. Select the "Enable continuous CTG measurement" check box to display the "Continuous CTG" menu in the patient app. Read more about CTG later in the manual.
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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.
Edit or delete a patient group
Click "Edit" to edit the patient group. Click "Update" to update and save. Click on "View" to see the patient group and get the option to delete the patient group.
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Patient Profiles
Create a Patient Profile
Click the "Create Patient" button. Enter the patient information in the fields displayed. Enter username and temporary password. Usernames must be unique in the system. Use the generated temporary password, or enter a new one; passwords must be at least eight characters long and contain at least one number.
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Note An asterisk (*) indicates mandatory fields to be filled out. The patient's "Health Care ID" is the unique patient identifier. Additional information (gray box) is provided if you hover over the field with the mouse. Enter the patient information in the fields displayed. |
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.
Click "Next.


Write / enter patient comments as needed. Click" Next. "
10b. Click" Add to Care Circle. "
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Enter the patient's relative contact information . Click" Save. "
Click" Add to Care Circle "to add a other relative contact information as needed. | 
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Patient information is displayed. Review patient information. Click 'Save'.
Patient information is displayed as shown below. When the patient menu is in a patient context, the patient information is displayed at a glance (e.g. , contact information and their relatives' contactinformation.) 
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Tip Check "stay signed in" at the beginning of the flow makes it possible for the patient to be logged automatically after the first login in patientappen. Use this function only if it is expected that the patient has trouble to log in as it allows anyone with access to the tablet to use the patient app.If "Stay logged in" is selected, a disclaimer m must be confirmed before "Create Patient" flow continues. |
Find a patient
Click "Find patient" in the main menu panel. Enter the patient's first name and last name. Make sure the status is set to "Active" in the drop-down menu. To fill in the form: Click on "Reset form" and enter new information as needed. Click on "Find patient". The patient's search results are displayed. Click on the patient's name to draw up the patient chart.
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Tip You can also search for a patient. Just click on the field on the Find Patient page, enter the information and click on "Find Patient". The patient's search results are displayed. | Search for Social security number Telephone number Username and / or patient group
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View and edit the patient's basic data
Click on "Basic data" in the patient menu Scroll to the bottom of the page and click on "Edit". In this section, you can enter and edit patient information, including:
Click "Update" when you have finished updating the information.
The patient data has been updated. | 
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Print Patient Master Data
Click “Basic Data” in the Patient Menu. Scroll down to the bottom of the page and click "Print."
This opens the print page. Make sure you select the correct printer / destination. Click "Print".
The document is printed. | 
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Reset a patient's password
Click "Basic data" in the patient menu Scroll to the bottom of the page and click "Reset password". "Are you sure you want to reset the password?" pop-up message appears. Click on "OK".
This will open a new page. A new temporary password is assigned to the patient.
Communicate the temporary password to the patient. | 
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Patient app logging
Setting up app logging for a patient
Click "Patient" from the administrator. Fill in the field "Username" and press "Find user". The patient's audit ID is displayed. Enter the duration of the time you want to log on to their activity. Click "Add".
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Views for which patient app logging is currently enabled. App logging is enabled until the date in "Active until"

Notes The Patient logging menu is used to set up logging in for a specific patient for a limited period of time. The audit ID is used to identify the patient's actions in the system logs. |
Audit logging
View audit logs
Click on "Audit log" from the administrator menu.
Here you can see all activity by user. 2. To search for specific logs, use the filters and click "Search". CPR number Username Area: function area Action: function detail From: start time for logs for review To: end time for logs for review Error: shows failed calls in the application
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Tip One or more filters can be specified in a single search. |
Info and guidance for patients
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.
CTG measurements
The option to record continuous CTGs is presented to the patient as a separate menu. The menu is only displayed for patients who are in a patient group that has continuous CTGs activated (see screenshot). | 
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Remarks CTG measurements can be captured in two ways: as continuous CTGs or as questionnaire-based CTGs. Continuous CTG acts as a stream, the patient begins to record, and the CTG data is displayed in the external viewer after a short delay. The measurement continues until the patient stops the measurement. Questionnaire-based CTGs are discrete measurements. They are captured as part of a questionnaire result. The patient starts his questionnaire and registers a CTG as with any other measurement. |
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
in the same way as all other measurements. A CTG-type measurement node is added to a questionnaire and that questionnaire is assigned to the patient. The patient will then be asked to perform a CTG measurement as part of this questionnaire. | 
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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:

Precautions
The information in this document is subject to change without notice.
Supplier
Levvel Health ApS
Savsvinget 7, 2970 Hørsholm
Denmark
Supplier responsibility
The supplier is only responsible for the software itself.