Instructions for use are supplied electronically, paper format is available on request at firstname.lastname@example.org
FibriCheck is a software on prescription or advise that determines heart rhythm conditions, with a primary focus on the detection of Atrial Fibrillation. The FibriCheck mobile application is only intended to record, display, store and transmit photoplethysmograms (PPG data). These recordings are performed by placing your finger on the camera of your mobile device thereby detecting the pulse waveform using the optical light and detector of a smartphone or other mobile device. The FibriCheck dashboard, a web application, is an online tool with the sole intention to display and store your data.
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. Recordings are stored on the smartphone and are automatically shared with the physician using the Internet. Medical professionals can use FibriCheck to screen for arrhythmias, remotely monitor and manage patients.
The FibriCheck Dashboard is a tool for medical professionals to manage and monitor patients which are using the FibriCheck App.
There are no known contraindications for FibriCheck.
The FibriCheck Dashboard is compatible with:
Users will always have access to the latest version of the FibriCheck Dashboard since it a secured website. They will be notified of the update. For latest updates in compatibility, check www.fibricheck.com/compatibility.
To access the dashboard FibriCheck you must sign in at app.fibricheck.com with the login credentials of the FibriCheck Mobile account. On the personal FibriCheck Dashboard only personal PPG signals of the measurements with the FibriCheck Mobile App are visualized.
If you lost your password, select Forgot your password? and enter your registered email address of FibriCheck. You will receive an email to reset your personal password.
To access the FibriCheck Dashboard, users must sign in at app.fibricheck.com with their personal FibriCheck account. If you lost your password, please select “Forgot Password?” and follow the instructions provided in the email.
Once signed in at the FibriCheck Dashboard, the Dashboard 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.
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.
This shows a list of all the patients associated with the account of the medical professional. Once a patient has activated the account, the patient can be found in this list. All measurements of these patients are visible for the professional user.
By selecting a patient, the detailed profile of the patient is shown. A general overview and calendar are displayed with a chronological timeline. On the right side a worklog can be find to add notes or comments.
A chronological oversight of the reports of all the patients is presented in this tab. All the reports appear in chronological order. In this summary it is possible to search a report by name or by the status of the report.
It is possible to investigate the report in more detail or to download the report for each patient. The reports present the measurements for each patient of the selected period. This period can be free determined. Each report illustrates the details of the patient, a general summary of all the measurements and a detailed overview of the selected measurements by color code.
It is also possible to obtain a report of a patient by clicking on the name of the patient. Afterwards a general summary of the report can be perceived underneath the section ‘reports’.
It is possible to have tailor-made reports. For this purpose you select the option ‘configuration’. It is possible to determine the content of the report by selecting the number of measurements of each color code, in demand of the report. It is also possible to select fixed moments to generate the reports. These settings can apply to all the reports or to an individual report of the patient. The settings applying to an individual report can be set in the detailed profile of the patient.
Prescriptions can be generated by clicking on the button ‘generate a prescription‘ in the menu bar. Select the physician for wich the prescription has to be generated. Select the payment method, patient or goup or credits. Afterwards you can select the prefered package.
Afterwards you can download the prescription and print it out or send it to the patient by email. Once the patient has scanned the QR code and has activated the account, his account will be connected to your dashboard and the measurements will be visualized.
FibriCheck is a software on prescription or advise of the physician. Without prescription you will not be able to activate your personal account.
Once a prescription is received, the FibriCheck app can be downloaded at the App Store or Google Play Store. Open the Store, search for “fibricheck” and download the app. A proper Internet connection is required to download FibriCheck. Once the download is complete, the app can be opened.
Select “I am new” to create a personal account. Follow the instructions presented on the screen of your smartphone. This information can be changed later in the app, if required. Once the registration process is completed, the figure on the prescription has to be scanned as indicated by the instructions presented.
If the user is instructed to pay the fee directly to Qompium, the user shall be able to choose between the following payment options by Visa card or MasterCard:
Furthermore, the user has also the option to pay by BC/MC but in such event, due to legal constraints, the User shall be obliged to pay the fee for the entire duration of the term as a one-off payment.
If you pay any fee with a credit card, Qompium may seek pre- authorization of your credit card account prior to your purchase to verify that the credit card is valid and has the necessary funds or credit available to cover your purchase.
Users can also complete the payment via pc or tablet. For this they have to consult payments.fibricheck.com and use their personal payment code which can be found on the prescription.
Once the registration is completed successfully, you can use the FibriCheck application. You can sign in by using the registered account information or personal pincode to unlock the app. The home screen of FibriCheck is presented and contains 4 different folders: FibriCheck, Measurement, Profile and Menu.
To view your previous measurements, you need to log in to the FibirCheck app. Once signed in, select "FibriCheck”. Next, select 'Measurement' to get an overview of all your previous measurements. These measurements are also shared with your centre responsible for the follow-up. The measurements are displayed chronologically, with the last measurement showed at the top.
Of every measurement the heart rate and respective color indication is shown, also date and time when the measurement was performed is displayed. When a measurement still needs to be revised, the measurement is preceded by a magnifying glass. This changes to a report when the monitoring center has revised the measurement.Color indication of a measurement:
If you think you may have an urgent medical emergency, please contact your physician or the emergency rescue immediately.Context of a measurement
If a previous measurement is selected, context of the measurement can be added or changed. For this, the figure indicating the mood should be selected. Press 'Save' to make the adjustments.Filter
To search for measurements, a filter is made available. The search can be based on color (green/orange/blue) or on review status. Select the filter-icon at the bottom right and tap the symbol you want to search for. To view all measurements, tap filter symbol X.
By notifications you can be notified of new messages, when a measurement has been reviewed, when your password has been changed… Preferences of these notifications can be adjusted under Menu > Preferences.
It is very important to comply with the following conditions when performing a measurement:
As soon as you unlocked the application, the startscreen of FibriCheck is shown. Select “Measurement” to start a measurement of your heart rhyhtm. A screen with instructions is shown how to perform a measurement correctly. Place your left (index)finger on the camera of the smartphone. FibriCheck will now detect the heart rate, this may take several seconds. A measurement takes 60s and is automatically forwarded to your monitoring centre via Internet. After the measurement, a context screen appears where more information can be added to the measurement. This ensures that the medical professional will get a better view on the situation resulting in an improved analysis. Please select how you feel and indicate if any symptoms are present. If required, an additional comment can also be added to a measurement which will be visible for the physician.
NOTE: If you get a pop-up message indicating an error in sending your measurement to your physician due to problems with Wi-Fi or Internet, the measurement will be automatically stored on your smartphone. Once the Internet connection is restored, the measurement is automatically forwarded.
Here personal information should be completed which will ensure that the medical professional has more information to assess the situation. It very important that this information is completed correctly.
This includes the medical professional or the monitoring center responsible for the revision of your measurements. The remaining number of days is also shown. This is the number of days the FibriCheck application will be available to monitor your heart rhythm. You will be notified in time when your prescription will expire. Ask your doctor to get a new prescription.
It is highly recommended to check your heart rhythm regularly. To ensure regular measurements, you can use this feature to be reminded by a notification on your smartphone. Select "New" to set a new reminder, choose the desired time and repetitions. Select ‘Save’ to set the reminders. Multiple reminders are possible.
In Menu, you can find information related to the FibriCheck account, set up personal preferences and change your pincode.
European conformity mark with number of Notified Body
|Instructions for use are available electronically for FibriCheck. These can be found in the app or on www.fibricheck.com.|
Manufacturer of the software and date of release:
Qompium NV (16-01-2017)
Kempische Steenweg 303/27, 3500 Hasselt
Reference of FibriCheck to identify the content
For more information or questions, please contact the helpdesk on email@example.com or by telephone at +32 11 48 59 53.