FibriCheck - Instructions For Use (iOS)

v1.1

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

Last updated: 23/11/2017

PRODUCT DESCRIPTION

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.

INTENDED 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. 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, while non-professional users have only permission to view their recordings at a personal FibriCheck Dashboard.

CONTRAINDICATIONS

There are no known contraindications for FibriCheck.

LIMITATIONS OF USE

COMPATIBILITY

FibriCheck Mobile Application

FibriCheck is a medical device regulated by CE. For this, proper testing and validation must be performed for each device as strict controls are required. We can assure compatibility for the following devices with iOS 10.0 or higher:

Every version of the FibriCheck Mobile Application will be blocked 1 year after its release. FibriCheck users will be notified when an update is available. The update of the FibriCheck Application can be found in the App Store

FibriCheck Dashboard

The FibriCheck Dashboard is compatible with:

Users will always have access to the latest version of the FibriCheck Dashboard since its a secured website. They will be notified of the update. For latest updates in compatibility, check www.fibricheck.com/compatibility.

CREATE A PERSONAL ACCOUNT

Step 1: Receive a prescription

FibriCheck is a software on prescription or advise of the physician. Without prescription you will not be able to activate your personal account.

Step 2: Download the app

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.

Step 3: Create a personal account

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.

Step 4: Complete the payment

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:

  • A one-off payment of the Fees for the entire duration of the Term;
  • Recurring payments of the Fees during the Term via an automatic monthly payment.
  • 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.

    Sign in in the mobile app

    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.

    FibriCheck

    Measurements

    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.

    Notifications

    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.

    Measurement

    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.

    Profile

    Personal information

    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.

    Follow-up

    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.

    Reminders

    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.

    Menu

    In Menu, you can find information related to the FibriCheck account, set up personal preferences and change your pincode.

    SYMBOLS USED

    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
    Belgium

    Reference of FibriCheck to identify the content

    HELPDESK

    For more information or questions, please contact the helpdesk on support@fibricheck.com or by telephone at +32 11 48 59 53.

    CONTACT DETAILS

    Qompium NV
    Kempische Steenweg 303/27
    3500 Hasselt
    Belgium
    www.fibricheck.com