Instructions for Use
17/10/2022 - v1
1. PRODUCT DESCRIPTION
FibriCheck is a software that determines heart rhythm conditions, with a primary focus on the detection of Atrial Fibrillation with a sensitivity and specificity of 91,86% and 97,59%, respectively.
The FibriCheck functionality is only intended to record, display, store and transmit photoplethysmogram (PPG) data. Recordings are performed by making contact between the skin and camera of a mobile device or by skin and sensor of a wearable device. This way, volumetric changes can be detected.
1.1 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.
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
FibriCheck cannot detect heart attacks or ischemic heart conditions. If you ever experience chest pain, pressure, tightness, or what you think is a heart attack, call emergency services.
A complete 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 labeling a measurement as regular or when feeling symptoms.
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
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 12.0.
4. A FIBRICHECK MEASUREMENT
4.1 Performing a measurement
Select the start button to start a measurement. A couple of instruction screens will show how to correctly perform a measurement. Place your (index)finger on the camera of the smartphone. FibriCheck will now detect your heart rhythm, this may take several seconds.
Once FibriCheck has started to record your heart rhythm, a visual graph is shown on the screen. A measurement takes the 60s. It is recommended to perform 2 measurements per day and additional ones when feeling symptoms.
It is very important to comply with the following when performing a measurement:
Make sure your hands and camera lens are clean;
Take a seated position and rest your arms on table;
Do not talk, move or relocate your finger during the measurement. This can interrupt the measurement or influence the quality of the measurement. In both cases, the measurement will have to be performed again;
Place your finger on the camera of your smartphone (it is not required to cover the flashlight of the camera).
4.2 After the 60 seconds measurement is completed
After completing the FibriCheck measurement, a context screen appears where more information can be added to the measurement. Please indicate what you were doing immediately before taking the measurement and whether you were experiencing any symptoms.
After every measurement, you will first receive an automatic interpretation by the FibriCheck algorithm about your heart rhythm. A pdf-file can be generated containing the results of your rhythm measurement. Your health care provider or monitoring center can overrule the FibriCheck interpretation.
Caution: This analysis is not a diagnosis and does not replace medical advice. Please seek professional medical assistance if you are, or believe you are, suffering from any medical problem. This device does not detect or monitor all heart rates, heart rhythms or heart waveform changes, especially those related to ischemic heart conditions. This interpretation is solely based on the PPG recording submitted for analysis.
4.3 Explanation of the rhythm classifications
Immediately, after a 60 second FibriCheck measurement, FibriCheck automatically interprets the signal. Possible outputs are the following alarms (low priority):
Green labelled as “Regular”: indicates that a low variability in the heart rhythm was detected during the measurement. This is indicative of a regular rhythm. FibriCheck cannot guarantee that no arrhythmia is present when a measurement is labeled as green.
NOTE: Please consult with your physician before making any medical decision, including altering your use of any drug or treatment.
Orange labelled as "Warning": rhythm variability is detected which might indicate possible finding of an arrhythmia such as ectopic beats, atrial fibrillation or any other arrhythmia.
NOTE: This analysis is not a diagnosis and does not replace medical advice. Please seek professional medical assistance if you are, or believe you are, suffering from any medical problem.
Red labelled as "Urgent": rhythm variability is detected which might indicate possible atrial fibrillation or atrial flutter.
NOTE: This analysis is not a diagnosis and does not replace medical advice. Please seek professional medical assistance if you are, or believe you are, suffering from any medical problem.
Blue labelled as “Signal Quality Too Low”: a recording where the quality of the recording could not be guaranteed and the user is prompted to try again. The insufficient quality could arise from a device deficiency or signal quality metric.
Please note:
Your physician or healthcare provider can overrule these interpretations.
The measurement is immediately analyzed by the FibriCheck algorithm and, when subscribed in the doctor model, also shared immediately with your healthcare provider who can overrule the interpretation. This might affect the graphical alarm.
If you are connected to the internet, you can instantly see if the interpretation by the algorithm has been overruled. If not connected, you will be notified as soon as the connection has been restored.
5. HYGIENIC MAINTENANCE
There are no special cleaning measures required for FibriCheck, though measurements should not be performed when the camera lens is unclean.
6. CYBERSECURITY
FibriCheck uses industry-standard encryption protocols to secure all products and data in transfer and at rest. FibriCheck uses industry best practices. Detailed measurement data is only stored on secure, encrypted servers and not on the device of the user. These databases contain encrypted user data when at rest or in transit. A continuous backup system is used to make sure all data is secure.
7. CONTACT DETAILS OF FIBRICHECK
Qompium Kempische Steenweg 303/27 3500 Hasselt Belgium
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