FibriCheck - Instructions For Use (Basic Dashboard)
Instructions For Use is supplied electronically, paper format is available on request at email@example.com
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.
LIMITATIONS OF USE
- FibriCheck records the heart rate and heart rhythm;
- Diagnosis can not be made based on FibriCheck alone;
- FibriCheck is an aid to the medical professional to monitor heart rate and heart rhythm;
- FibriCheck does not detect or measure all heart rates, heart rhythm and heart waveform changes;
- Interpretations made by FibriCheck are potential findings. All interpretations should be reviewed by a medical professional;
- FibriCheck is not intended to be used by persons with colored fingers (i.e. tattoo’s, ink);
- FibriCheck is not intended to be used by minors (below 18 years old);
- FibriCheck is not intended to be used by users with a pacemaker, or any implantable device that paces the heart;
- FibriCheck is not intended to be used by users with conditions causing tremors or inability to hold the hands still for at least 60 seconds. (e.g. Parkinson or dementia);
- FibriCheck is not intended to be used by persons with reduced blood flow in the fingertips (e.g. perniosis);
- FibriCheck is not intended to be used by users that have a disability to perform the measurement according to the instructions for use.
The FibriCheck Dashboard is compatible with:
- Google Chrome (58 or higher)
- Internet Explorer (11 or higher)
- Mozilla Firefox (52 or higher)
- Safari (8 or higher)
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.
THE FIBRICHECK DASHBOARD
To access the dashboard FibriCheck you can log on 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 have forgotten your password, select Forgot your password? and enter your email registered email address of FibriCheck. You will receive an e-mail to set your personal password
FIBRICHECK MOBILE APP
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:
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.
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:
- Green: indicates low variability in the heart rhythm is detected during the measurement. This indicates a normal sinus rhythm. FibriCheck can not guarantee that no arrhythmia is present when a measurement is labeled as green.
- Orange: rhythm variability is detected which might indicate possible finding of an arrhythmia such as extrasystoles, atrial fibrillation or other arrhythmia.
- Blue: a blue color indicates whether the quality of the registered signal was not sufficient to be interpreted.
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:
- Make sure your hands and camera lens are clean;
- Sit down and relax. Put the forearms on a table;
- Do not talk, move or relocate your finger during the measurement. This can influence the quality of the measurement. If there is too much noise, the measurement will be aborted;
- Place your (index) finger on the camera of your smartphone.
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 firstname.lastname@example.org or by telephone at +32 11 48 59 53.
CONTACT DETAILSQompium NV
Kempische Steenweg 303/27