# Instructions for Use - Dashboard

# Instructions for Use - Portal

# 2.9

2024-06-14

Instructions for use are supplied electronically, paper format is available on request at support@fibricheck.com

# 1. PRODUCT DESCRIPTION

FibriCheck is a software that determines heart rhythm conditions, with a primarily focus on the detection of Atrial Fibrillation.

The FibriCheck Mobile application is intended to record, display, store and transmit photoplethysmogram (PPG) data. Recordings are performed by making contact between skin and camera of a mobile device or by skin and sensor of a wearable device. This way, volumetric changes can be detected.

Additionally, the FibriCheck Mobile application may be used to store systolic and diastolic blood pressure values, which are classified according to the 2018 ESC/ESH Guidelines for the Management of Arterial Hypertension. No further detection or analysis is done based on these values, nor does the FibriCheck Mobile application function as a measurement device. Blood pressure data must be entered manually and should be measured by a medically certified blood pressure monitor device.

The sole purpose of the FibriCheck Dashboard/Portal application, an online tool, is to display data that was captured by or entered in the FibriCheck Mobile application. Professional users can use the Dashboard/Portal to manage patients and review FibriCheck data.

# 1.1 Indications for use

Indications for use
Adults with known or suspected heart conditions such as Atrial Fibrillation can use the FibriCheck application daily, or whenever feeling symptoms, to record their pulse waveform and to monitor their heart rhythm.
Indications for use (US only)
FibriCheck is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.

# 1.2 Contraindications

There are no known contraindications for FibriCheck.

# 1.3 Guidelines for use

FibriCheck can be used anytime and anywhere as long as it is used on a compatible, functioning mobile or wearable device with sufficient battery. If there is no internet connection, a measurement can still be performed, but the measurement analysis will only be available after the connection has been restored as the information must be sent to the cloud for proper analysis.

# 2. RECOMMENDATIONS

# 2.1 General

A diagnosis cannot be made based on FibriCheck alone, consult with your physician before making any medical decision, including altering your medication or treatment.
FibriCheck does not detect or register all changes in heart rates, heart rhythms and heart waveform.
Interpretations made by FibriCheck are potential findings, not a complete diagnosis of cardiac conditions. All interpretations should be reviewed by a medical professional for clinical decision making.
Do not perform measurements while driving or during physical activity.
Do not perform measurements when the camera lens is uncleaned or broken.
After PPG analysis, the app may incorrectly identify some conditions as unreadable. Please consult with your physician.
FibriCheck does not guarantee that you are not experiencing an arrhythmia or other health conditions when labelling a measurement as normal. You should notify your physician for possible changes in your health.
Do not continue using FibriCheck when experiencing discomfort caused by the camera flash. Try to avoid overlap of the flashlight with the finger.
Measurements can’t be sent to your physician without Internet connection.

# 2.2 Users

FibriCheck is not intended to be used by all individuals:

Persons with coloured fingers/wrist (i.e. tattoos, ink); unnaturally coloured fingers/wrist weaken the signal and interfere with the effectiveness of the device (depending on the device).
Persons under the age of 18 years.
Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device cannot process an accurate measurement.
Persons with reduced blood flow in the fingertips (e.g. perniosis or callus formation) as FibriCheck will not be able to detect the significant intensity variations induced by the blood flow.
Persons that have a disability to perform the measurements according to the instructions for use.
Persons with cardiac pacemakers, ICDs, or other implanted electronic devices as these can control the natural heart rhythm.

# 3. COMPATIBILITY

# 3.1 FibriCheck Dashboard / FibriCheck Portal

The FibriCheck Dashboard/Portal, an online tool, has the sole intention to display data and is compatible with:

Google Chrome (58 or higher)
Microsoft Edge
Mozilla Firefox (52 or higher)
Safari (8 or higher)

Users will always have access to the latest version of the FibriCheck Dashboard/Portal since its a secured website. They will be notified of the update.

# 3.2 FibriCheck Mobile Application

The minimum system requirements for the FibriCheck smartphone application are an Android operating system with minimal software version Android 5.0 or an iOS operating system with minimal software version iOS 15.0.

FibriCheck users will be notified when an update is available. The update of the FibriCheck Application can be found in the App Store / Play Store.

NOTE: FibriCheck performs proactive device monitoring. If you cannot find the application in the App Store / Play Store, this is preventively removed.

# 4. THE FIBRICHECK DASHBOARD

This section applies only to the FibriCheck Dashboard application. To access the FibriCheck Dashboard, users must sign in at dashboard.fibricheck.com (opens new window) with their personal FibriCheck account. If you lost your password, please select “Forgot Password?” and follow the instructions provided in the email.

# 4.1 Dashboard

Once signed in to the application, the Dashboard page is automatically visible. A general overview is given of all measurements open waiting for revision. The measurements are classified in different categories: Urgent, Warning, Normal and Quality. All measurements are chronological ranked in these categories.

# 4.2 Work List

Under the menu ‘Worklist’ the list of measurements which are open for revision can be found. These measurements are arranged chronologically. For each measurement the color indication and the username are shown. Select a measurement to view it. The color indicator and interpretation of the measurement must be confirmed. Additional comments can be added.

A search for a specific measurement of a patient or search on color indication can be done in the toolbar.

# 4.3 Patients

The Patient List displays all of your patients, including various metrics such as prescription information, last measurement and last most severe measurement.

Clicking on measurement timestamps will open a drawer where the measurement's details are shown. Clicking on a patient's name will take you to the Patient Details. You can also use various sorting and filtering. Your sort and filter settings will be saved and re-applied when returning to the list.

# 4.3.1 Patient Details

Patient Details (opened whenever clicking on a patient's name) show an overview of the selected patient:

Use the 'Create Report' button to create customized reports
Use the 'Notes' button to open logging functionality
The patient's prescriptions are shown, including start- and end-dates. Click 'see more' to see all previous prescriptions
The patient's heart rate & rhythm details are shown, covered by several graphs, tables and a calendar
If enabled for your group, the patient's blood pressure details are shown
The patient's latest reports are shown - alternatively, use the 'Reports' tab to show all of the patient's reports
On the Personal & health info tab, the patient's name, e-mail, telephone, birth date, ..., and answers to the medical questionnare are shown.

Use the date picker fields to select a date range of your choice.

Some graphs are interactive, meaning that you can zoom in/out, or click on indicators in the legend to show or hide them.

To show measurement details, click on a data point in one of the graphs or on a measurement in the calendar. This will open the measurement details, showing details such as symptoms, symptom severity, PPG signal graph, tachogram, Lorenz plot in case of heart rhythm measurements. In case of blood pressure data points (if enabled for your group) you will see the blood pressure details.

# 4.4 Reports

The Reports page shows an overview of all of your patient's reports. Use the filters to find a report. Click on the download icon to download a report.

# 4.5 Group settings

Group settings contain all of your group's configuration. Use the 'visible' checkbox to finetune the displayed data: if disabled, all of the group's data (including patients and measurements) will be hidden on all pages. If enabled, all data will be shown.

Click on a group name to open the group's specific settings. The General tab includes name, description, language, ... settings. Reporting rules of the group can also be adjusted here, such as the activation of a weekly or montly report, a prescription end report, and the amount of measurements included in such reports.

# 4.8 Profile settings

Click on your name on the top right to open your profile settings. This is where you can update account details, change your password, and enable 2-step verification.

# 5. THE FIBRICHECK PORTAL

This section applies only to the FibriCheck Portal application. To access the FibriCheck Portal, users must sign in at portal.fibricheck.com (opens new window) with their personal FibriCheck account. If you lost your password, please select “Forgot Password?” and follow the instructions provided in the email.

# 5.1 Dashboard

Once signed in to the application, the Dashboard page is automatically visible. The page contains four widgets, displaying various information about your patients. The information is clickable, which will redirect you to the corresponding page. For instance, clicking on the number of new urgent alerts will redirect you to the Work List, where those alerts are filtered.

# 5.2 Work List

The Work List displays triggered alerts for your groups, as configured on Group Settings > Select your group > Alerts. Using the alerting system allows for action-based methods of working.

The following alerts are available:

Prescription ended: warning: A user’s prescription end report with at least one orange (warning) measurement and no urgent (red) measurements is ready. Default priority: high
Prescription ended: urgent: A user’s prescription end report with at least one red (urgent) measurement is ready. Default priority: critical
Prescription ended: quality: A user’s prescription end report with at least one blue (quality) measurement and no red, orange, or green measurements is ready. Default priority: low
Prescription ended: normal: A user’s prescription end report with at least one green (normal) measurement and no red (urgent) or orange (warning) measurements is ready. Default priority: medium
Prescription ended: empty: A user’s prescription end report that contains no measurements is ready. Default priority: low
First recording: warning: A user’s first recording of an orange (warning) label, for a reviewed measurement, within the timeframe of an active prescription. This alert is triggered only once per measurement, and includes the most severe label. Default priority: high
First recording: urgent: A user’s first recording of a red (urgent) label, for a reviewed measurement, within the timeframe of an active prescription. This alert is triggered only once per measurement, and includes the most severe label. Default priority: critical.

Click on the checkmark icon to acknowledge an alert. You can also select multiple alerts and acknowledge them simultaneously. Click on the report icon to see the alert's details - for example, the PDF report or to open the corresponding measurement. Click on the notebook icon to leave a comment. Acknowledged alerts will disappear from the standard view. To show these, filter on acknowledged alerts. From here, their status can also be reverted.

The list refreshes automatically every 30 seconds.

# 5.3 Patients

The Patient List displays all of your patients, including various metrics such as prescription information, last measurement and last most severe measurement.

# 5.3.1 Patient Details

Patient Details (opened whenever clicking on a patient's name) show an overview of the selected patient:

Use the 'Send Notification' button to send a customized push notification to your patient. The notification will be visible in their FibriCheck mobile app
Use the 'Create Report' button to create customized reports
Use the 'Notes' button to open logging functionality
The patient's prescriptions are shown, including start- and end-dates. Click 'see more' to see all previous prescriptions
The patient's heart rate & rhythm details are shown, covered by several graphs, tables and a calendar
If enabled for your group, the patient's blood pressure details are shown
The patient's latest reports are shown - alternatively, use the 'Reports' tab to show all of the patient's reports
On the Personal & health info tab, the patient's name, e-mail, telephone, birth date, ..., and answers to the medical questionnare are shown. Here you can also assign a custom ID to your patient.

Use the date picker fields to select a date range of your choice.

Some graphs are interactive, meaning that you can zoom in/out, or click on indicators in the legend to show or hide them.

To show measurement details, click on a data point in one of the graphs or on a measurement in the calendar. This will open the measurement details drawer, showing details such as symptoms, symptom severity, PPG signal graph, tachogram, Lorenz plot in case of heart rhythm measurements. In case of blood pressure data points (if enabled for your group) you will see the blood pressure details.

Within the measurement details drawer, use the left or right arrow buttons on top to navigate between measurements. Use the comment icon to leave a comment for the specific measurement (or see the patient's comments). Use the pencil icon to revise the measurement. Use the download icon to download the measurement report.

# 5.4 Reports

The Reports page shows an overview of all of your patient's reports. Use the filters to find a report. Click on the download icon to download a report.

# 5.5 Group settings

The Alerts tab is where you can set up alerts for your group, that will show up on the Work List when triggered. (Re)enabling an alert will also allow you to adjust its priority.

Modules shows an overview of the modules enabled for your group.

# 5.6 Feedback

Use the Feedback page to submit your feedback about the application.

# 5.7 Support

The Support section of the navigation bar contains various links to support documentation.

# 5.8 Profile settings

Click on your name on the bottom left to open your profile settings. This is where you can update account details, change your password, and enable 2-step verification.

# 6. COLOR INDICATIONS OF FIBRICHECK HEART RHYTHM MEASUREMENTS

The FibriCheck Dashboard/Portal displays data captured with the FibriCheck Mobile application.

# 6.1 Heart rate

Low: indicates the heart rate detected was below 50 beats per minute (bpm).
Normal: indicates a heart rate between 50-100 bpm was detected.
High: indicates when a heart rate above 100 bpm was detected.
Analysis not possible: indicates whether the quality of the registered signal was not sufficient to be interpreted.

# 6.2 Heart rhythm

Green: indicates low variability in the heart rhythm is detected during the measurement. This indicates a normal sinus rhythm. However, FibriCheck can not guarantee that no arrhythmia or other cardiac condition is present when a measurement is labeled as regular.
Orange: low rhythm variability is detected which might indicate possible finding of an arrhythmia such as extrasystoles or other arrhythmia.
Red: high rhythm variability is detected which might indicate possible finding of an arrhythmia such atrial fibrillation or other arrhythmia.
Blue: a blue color indicates whether the quality of the registered signal was not sufficient to be interpreted.

# 7. PRESCRIPTIONS

Your patients need a prescription to use the FibriCheck Mobile application. By activating the prescription, they will be added to the chosen group and you be able to see the patient's measurement data.

# 7.1 New patients

If you want to prescribe to a new patient, you can click on the button 'Create prescription’ in the menu bar and complete the details of the prescription per instructions. Afterwards, you can download and print the prescription or send the prescription via email to the patient.

# 7.2 Reactivate patient

If you want to reactivate a prescription for a specific patient, go to the patient list and look for the patient. On the right side in the patient overview, a blue button is visible. Click the button and follow the instructions.

# 8. APPLICABLE SYMBOLS

Symbol	Detail
	Indicates the software is a registered Medical Device
	European Conformity Mark with Notified Body Number
	Consult electronic instructions for use (eIFU) with appropriate indication
	Manufacturer details including date of release

# 9. CONTACT DETAILS

For more information or questions, please check our FAQ at help.fibricheck.com (opens new window).

Serious incidents that have occurred in relation to the device shall be reported to:
(1) the legal manufacturer via support@fibricheck.com
(2) the local competent authority

# 9.1 Manufacturer

Qompium

Kempische Steenweg 303/27
3500 Hasselt
Belgium

Emergo Australia

Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia

# 9.3 Swiss Authorised Representative

OMCS Medical GmbH.
C/O Mr Wilhelm Gudelow
Aegeristrasse 5
6300 Zug
Switzerland
AR@omcmedical.com