You find Terms of Use long, difficult and full of legalese? We do too. However, we find it important to inform you about the way you can make use of the FibriCheck Services. That’s why we made this 2-minute-read summary for you. This summary will provide you with the necessary information and all you need to know in no-time!
FibriCheck Terms of Use
1.5.0
2022-05-09
The present terms of use (the “Terms of Use”) are supplied electronically for the use of the FibriCheck Services (as defined hereafter).
By using the FibriCheck Services, you accept our Terms of Use. So please make sure you carefully read the Terms of Use before using the application.
1. Summary
1.1 First things first, who are we?
The FibriCheck Services are managed by Qompium NV, a company incorporated under Belgian law, having its registered address at Kempische Steenweg 303/27, 3500 Hasselt, Belgium (“Qompium”).
Qompium NV has developed a software solution to determine heart rhythm conditions, with a primary focus on the timely detection of atrial fibrillation (“FibriCheck Services” or “FibriCheck”).
FibriCheck is certified as a medical device in Europe (CE-Class IIa), USA (FDA-cleared), Australia (TGA-cleared) and Saudi Arabia (SFDA-cleared).
A diagnosis though is always made by a physician and FibriCheck can never replace any medical advice, diagnosis or treatment. If you think you may have a medical emergency, please contact your physician or emergency services immediately.
1.2 When and how can you use the FibriCheck Services?
To use FibriCheck, you must accept our Terms of Use. They set out the rules for using our FibriCheck Services.
To subscribe to FibriCheck, you must be at least 18 years old.
You may only use our service as it’s intended and you are together with us, responsible for the confidentiality of your use.
If you violate our Terms of Use, you risk no longer being able to use FibriCheck.
1.3 Also important to know:
Qompium will always remain the owner of the services (including the FibriCheck Services) and of all related intellectual property rights.
The liability of Qompium with regard to its services (including the FibriCheck Services) is excluded and limited to the maximum extent permitted by law and we do not provide any warranties.
Our Terms of Use may be updated from time to time.
For more information regarding your use of FibriCheck, we invite you to read our complete Terms of Use, where everything is explained in detail.
2. Introduction
Welcome to FibriCheck, an innovative application to detect cardiac arrhythmias, provided by Qompium (also “FibriCheck” or “We” or “Us”).
The use of the FibriCheck Services is subject to your agreement with all our Terms of Use. The FibriCheck Services are managed by Qompium.
We may modify these Terms of Use at any time, and such modifications shall be effective immediately upon posting the modified Terms of Use of the FibriCheck Services. By continuing to use FibriCheck Services, you are deemed to have accepted any updated terms and conditions.
If you do not accept these updated Terms of Use or do not wish to be bound by changes following posted notices you should discontinue use of the FibriCheck Services.
Please review the Terms of Use carefully before using the FibriCheck Services. In addition to these Terms of Use, the FibriCheck Services are also governed by our Instructions for Use, which form your integral contractual relation with FibriCheck.
If you have any questions about the FibriCheck Services or the Terms of Use, please contact us via support@fibricheck.com.
3. FibriCheck Services
FibriCheck is an application that determines heart rhythm conditions, with a primary focus on the timely detection of atrial fibrillation.
FibriCheck is available as a separate application in several countries, but You are using the FibriCheck Services integrated into a third party application that you use. Through this application, you will be able to perform FibriCheck measurements and to receive an analysis on the presence of cardiac arrhythmias.
The goal of the FibriCheck Services is to help you to timely detect cardiac arrhythmias by monitoring and tracking your heart rhythm over time and to provide you with the opportunity to assess your cardiovascular risk profile.
The FibriCheck Services allow you to perform an unlimited amount of measurements via the third party application. Measurements are performed by placing the finger on the camera of your mobile device for 60 seconds. During this measurement we are detecting the pulse waveform using the optical light and detector of the mobile device. The measurements will then be assessed by the FibriCheck algorithms for the presence of cardiac arrhythmias, whereby we focus on detecting atrial fibrillation. All the measurements labelled orange or red will be revised by the Expert Review Team for confirmation. FibriCheck will provide feedback when your measurement has been revised by FibriCheck’s expert review team (the “Expert Review Team”).
The findings obtained by the Expert Review Team are exclusively intended for information purposes and under no circumstances do they replace personal diagnostics, consultations, care or treatment by medical or other medically trained personnel. The possibility of a misinterpretation by the medical technicians cannot be ruled out. The Expert Review service is not designed to be an aid in either decision-making for acute states or for real-time monitoring of vital functions. The Expert Review Team and its executive bodies, executives, employees, vicarious agents, partners, affiliates and licensors assume no responsibility whatsoever for decisions made by you based on the information, such as decisions as to whether or not to consult caregivers or accept treatment by medical or healthcare professionals. These FibriCheck Services do not render, nor are they intended as a substitute for the provision of any medical care.
At the end of your FibriCheck use, you will receive a full comprehensive report, including the details of your measurements, educational information and statistics. Furthermore, the report will include details about the preferred next steps to take. Your report will be available in the third party application.
The goal of FibriCheck is to help you understand your heart health and does not provide you with a diagnosis for cardiac arrhythmias. If you think you may have a medical emergency, please contact your physician or emergency services immediately.
It is advisable that the healthcare facility verifies related quality certifications of the software.
4. Applicability
By accepting the Terms of Use you expressly confirm that you have access to the intended use of the FibriCheck Services as set out in the present Terms of Use. As a result thereof, you confirm and accept that you waive your right of revocation as soon as the FibriCheck Services are supplied by FibriCheck. This means that from this time forward, you are under obligation to comply with the terms and conditions of the present Terms of Use.
Where the FibriCheck Services or the website https://www.fibricheck.com draws on services from third parties, the terms and conditions of service delivery of the said third parties may apply. By using such services from a third party, you accept the applicable terms and conditions. FibriCheck declines all and any liability for the substance of the terms and conditions of the third parties.
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7. Use of the FibriCheck Services
FibriCheck recommends you to read the Instructions for Use before you use the FibriCheck Services. Please note that the FibriCheck Services are not directed towards and may not be used by minors.
FibriCheck is intended to timely detect cardiac arrhythmias with a focus on atrial Fibrillation. We advise you to not use FibriCheck if:
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).
Minors (below 18 years old); the device has not been evaluated in persons where the heart is not fully grown.
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.
In order to use all functionalities of FibriCheck, you will need Wi-Fi on your mobile device or mobile Internet connection. Access to Wi-Fi or a mobile Internet connection is your own responsibility. Please make sure your mobile device complies with the minimum system requirements as specified on the download page.
If your mobile device does not meet these minimum system requirements, we are unable to guarantee that FibriCheck will work properly. FibriCheck declines all and any liability for loss or damage due to the fact that you failed to comply with the aforesaid requirements.
During your subscription period, we may, in our sole discretion, provide you with updates. For the avoidance of doubt, we are not obligated to provide any updates of the FibriCheck Services.
8. License - restrictions
8.1 License by FibriCheck
During the subscription period and subject to the timely payment of the fees (if applicable), we grant you a non-exclusive, personal, restricted, non-sublicensable and non-transferable license to use the FibriCheck Services in accordance with these Terms of Use ("License"). You are not allowed to use the FibriCheck Services for any commercial purposes or to use the FibriCheck Services, or a component of the foregoing in a manner not authorized by us. You shall use the FibriCheck Services solely in full compliance with (i) the present Terms of Use; (ii) any additional instructions or policies issued by us, including, but not limited to, those posted within the third party application or on our website https://www.fibricheck.com; (iii) any applicable legislation, rules or regulations and (iv) additional documentation provided.
8.2 Restrictions.
You agree to use the FibriCheck Services only for their intended use as set forth in this Agreement. Within the limits of the applicable law, you are not permitted to (i) make the FibriCheck Services and/or additional provided documentation available or to sell or rent the FibriCheck Services and/or additional provided documentation to any third parties, without explicit written consent of us; (ii) adapt, alter, translate or modify in any manner the FibriCheck Services or additional provided documentation; (iii) sublicense, lease, rent, loan, distribute, or otherwise transfer the FibriCheck Services or additional provided documentation to any third party; (iv) decompile, reverse engineer, disassemble, or otherwise derive or determine or attempt to derive or determine the source code (or the underlying ideas, concepts, algorithms, structure or organization) of the FibriCheck Services or additional provided documentation, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation; (v) use or copy the FibriCheck Services or additional provided documentation except as expressly allowed under this Article 8; (vi) gain unauthorized access to Accounts of other users or the IT equipment or structure of us to provide the FibriCheck Services or additional provided documentation or use the FibriCheck Services or additional provided documentation to conduct or promote any illegal activities; (vii) use the FibriCheck Services or additional provided documentation to generate unsolicited email advertisements or spam; (viii) impersonate any person or entity, or otherwise misrepresent your affiliation with a person or entity; (iv) use any high volume automatic, electronic or manual process to access, search or harvest information from the FibriCheck Services or additional provided documentation (including without limitation robots, spiders or scripts); (x) alter, remove, or obscure any copyright notice, digital watermarks, proprietary legends or other notice included in the FibriCheck Services or additional provided documentation; (xi) intentionally distribute any worms, Trojan horses, corrupted files, or other items of a destructive or deceptive nature or use the FibriCheck Services or additional provided documentation for any unlawful, invasive, infringing, defamatory or fraudulent purpose; or (xii) remove or in any manner circumvent any technical or other protective measures in the FibriCheck Services or additional provided documentation.
Except as expressly set forth herein, no express or implied license or right of any kind is granted to you regarding the FibriCheck Services or additional provided documentation or any part thereof, including but not limited to any right to obtain possession of any source code, data or other technical material relating to the FibriCheck Services.
8.3 License by user
By uploading, creating or otherwise providing information, data or images on or through the FibriCheck Services ("User Content"), you grant us a non-exclusive, royalty-free, worldwide, sublicensable, transferable, license to use, copy, store, modify, transmit and display User Content to the extent necessary to provide and maintain the FibriCheck Services. We reserve the right, but are not obliged, to review and remove any User Content which is deemed to be in violation with the provisions of the Terms of Use or otherwise inappropriate, any rights of third parties or any applicable legislation or regulation.
9. Ownership
As between you and us, the FibriCheck Services, our website https://www.fibricheck.com and all additional documentation provide, all worldwide Intellectual Property Rights pertaining thereto, are the exclusive property of us and/or its licensors.
Intellectual Property Rights are defined as any and all now known or hereafter existing (a) rights associated with works of authorship, including copyrights, mask work rights, and moral rights; (b) trademark or service mark rights; (c) trade secret rights, know-how; (d) patents, patent rights, and industrial property rights; (e) layout design rights, design rights, (f) trade and business names, domain names, database rights, rental rights and any other industrial or intellectual proprietary rights or similar right (whether registered or unregistered); (g) all registrations, applications for registration, renewals, extensions, divisions, improvements or reissues relating to any of these rights and the right to apply for, maintain and enforce any of the preceding items, in each case in any jurisdiction throughout the world;
All rights in and to the FibriCheck Services and/or additional documentation provided not expressly granted to you in this Terms of Use are reserved by us and our licensors. Except as expressly set forth herein, no express or implied license or right of any kind is granted to you regarding the FibriCheck Services and/or additional documentation provided or any part thereof, including any right to obtain possession of any source code, data or other technical material related to the FibriCheck Services or our website.
10. Feedback
It is expressly understood, acknowledged and agreed that you shall, regardless of whether or not formally requested to do, provide to FibriCheck reasonable suggestions, comments and feedback regarding the FibriCheck Services, including but not limited to usability and test results (collectively, “Feedback”). If you provide such Feedback to FibriCheck, you shall grant FibriCheck the following worldwide, non-exclusive, perpetual, irrevocable, royalty free, fully paid up rights:
to make, use, copy, modify, sell, distribute, sub-license, and create derivative works of, the Feedback as part of any FibriCheck product, technology, services (including the “FibriCheck Services”), specification or other documentation (individually and collectively, "FibriCheck Product(s)");
to publicly perform or display, import, broadcast, transmit, distribute, license, offer to sell, and sell, rent, lease or lend copies of the Feedback (and derivative works thereof) as part of any FibriCheck Product;
Further, you warrant that its Feedback is not subject to any license terms that would purport to require FibriCheck to comply with any additional obligations with respect to any FibriCheck Products that incorporate any Feedback.
11. Suspension
If we become aware or suspects, in our sole discretion, any violation by you of these Terms of Use or any other instructions, guidelines or policies issued by us, then we may suspend or limit your access to the FibriCheck Services. The duration of any suspension by FibriCheck will be until you have cured the breach which caused such suspension or limitation.
12. Liability
To the maximum extent permitted under applicable law, our liability arising out of or in connection with the FibriCheck Services under these Terms of Use whether in contract, warranty, tort or otherwise, shall not exceed the amount paid out under our compulsory insurance policy at the date on which the applicable liability claim arises. Nothing in these Term of Use shall limit or exclude our liability for (i) gross negligence; (ii) willful misconduct, (iii) fraud or personal injury.
To the extent legally permitted under applicable law, we shall not be liable to you or any third party, for any special, indirect, exemplary, punitive, incidental or consequential damages of any nature including, but not limited to damages or costs due to loss of profits, data, revenue, goodwill, production of use, procurement of substitute services, or property damage arising out of or in connection with the FibriCheck Services under these Terms of Use, including but not limited to any miscalculations, or the use, misuse, or inability to use the FibriCheck Services or other documentation provided, regardless of the cause of action or the theory of liability, whether in tort, contract, or otherwise, even if we have been notified of the likelihood of such damages. The limitation in this Article 12.2 shall not apply to the obligations of FibriCheck under Article 13 ("Indemnification").
You agree that we can only be held liable as per the terms of this Article 12 to the extent damages suffered by you are directly attributable to us. For the avoidance of doubt, we shall not be liable for any claims resulting from (i) your unauthorized use of the FibriCheck Services, (ii) your or any third party's modification of (any parts) of the FibriCheck Services, (iii) your failure to use the most recent version of the FibriCheck Services made available to you or your failure to integrate or install any corrections to the FibriCheck Services issued by us, or (iv) your use of the FibriCheck Services in combination with any non-FibriCheck products or services. The exclusions and limitations of liability under this Article shall operate to the benefit of our affiliates and subcontractors under this Terms of Use to the same extent such provisions operate to our benefit.
13. Warranties and disclaimers
13.1 By Us
Except as expressly provided in this Article 13 and to the maximum extent permitted by applicable law, the FibriCheck Services, including the analysis of your measurements by our algorithm or expert review team are provided "AS IS" and we make no (and hereby disclaims all) other warranties, covenants or representations, or conditions, whether written, oral, express or implied including, without limitation, any implied warranties of satisfactory quality, course of dealing, trade usage or practice, merchantability, suitability, availability, title, noninfringement, or fitness for a particular use or purpose, with respect to the use, misuse, or inability to use the FibriCheck Services, , including the analysis of your measurement by our algorithm or expert review team, (in whole or in part) or any other products or services provided to you by us. We do not warrant that (i) all errors can be corrected, or that access to or operation of the FibriCheck Services shall be uninterrupted, secure, or error-free, and (iii) the information, including but not limited to the analysis of your measurements by our algorithm or expert review team, available on or transmitted by the FibriCheck Services, is true, complete or accurate. You specifically acknowledge and agree that we cannot be held liable for any healthcare or related decisions made by you or your physician based upon the analysis of your measurements by our algorithm or the Expert Review Team, transmitted or displayed by or on the FibriCheck Services whether such data is accurate or inaccurate. You acknowledge and agree that your physician, and not we, is solely responsible for the interpretation of your measurements or other healthcare information related to you. You expressly acknowledge and agree that your use of the FibriCheck Services including the analysis of your measurements, is at your sole risk. You acknowledge and agree that there are risks inherent to transmitting information over and storing information on the internet and that we are not responsible for any losses of your data, including but not limited to the analysis of the measurements and any user content, in connection therewith.
We shall defend and indemnify you as specified herein against any founded and well-substantiated claims brought by third parties to the extent such claim is based on an infringement of the Intellectual Property Rights of such third party by the FibriCheck Services and excluding any claims resulting from (i) your unauthorized use of the FibriCheck Services, (ii) your or any third party's modification of any of the FibriCheck Services, our website or additional provided documentation, (iii) your failure to use the most recent version of the FibriCheck Services made available to you, or your failure to install any corrections or updates to the FibriCheck Services issued by us, if we indicated that such update or correction was required to prevent a potential infringement, or (iv) your use of the FibriCheck Services in combination with any non-FibriCheck Products or services.
Such indemnity obligation shall be conditional upon the following: (i) we are given prompt written notice of any such claim; (ii) we are granted sole control of the defense and settlement of such a claim; (iii) upon our request, you fully cooperates with us in the defense and settlement of such a claim, at our expense; and (iv) you make no admission as to our liability in respect of such a claim, nor do you agree to any settlement in respect of such a claim without our prior written consent. Provided these conditions are met, we shall indemnify you for all damages and costs incurred by you as a result of such a claim, as awarded by a competent court of final instance, or as agreed to you pursuant to a settlement agreement.
In the event the FibriCheck Services, in our reasonable opinion, are likely to or become the subject of a third-party infringement claim (as per this clause 12.1), we shall have the right, at our sole option and expense, to: (i) modify the ((allegedly) infringing part of the) FibriCheck Services so that they become non- infringing while preserving equivalent functionality; (ii) obtain for you a license to continue using the FibriCheck Services in accordance with these Terms of Use; or (iii) terminate the Licence and pay to you an amount equal to a pro rata portion of the Fees for that portion of the FibriCheck Services which is the subject of such infringement.
The foregoing states the entire liability and obligation of us and the sole remedy of you with respect to any infringement or alleged infringement of any Intellectual Property Rights caused by the FibriCheck Services or any part thereof.
13.2 By You
You represent and warrant us that (a) you have the authority to enter into this binding agreement personally and (b) that any User Content provided by you for the use of the FibriCheck Services is accurate and truthful and shall not (i) infringe any Intellectual Property Rights of third parties; (ii) misappropriate any trade secret; (iii) be deceptive, defamatory, obscene, pornographic or unlawful; (iv) contain any viruses, worms or other malicious computer programming codes intended to damage our system or data; or (v) otherwise violate the rights of a third party.
You agree and acknowledge that we are not obligated to back up any User Content and/or measurements. You agree that any use of the FibriCheck Services contrary to or in violation of the representations and warranties of you in this Article constitutes unauthorized and improper use of the FibriCheck Services
14. Term and termination
We shall grant you a license on the FibriCheck Services during your subscription period unless the license is terminated in accordance with Article 14 of these Terms of Use. During your subscription period, you will be eligible to receive all major and minor updates and upgrades for the FibriCheck Services.
For the avoidance of doubt, in the event you remove the third party application from your mobile device or smartwatch before the expiration of the subscription period, the User is not entitled to a refund of any pre-paid Fees for the remaining period of the subscription.
Upon expiration of the subscription, any user rights on the FibriCheck Services that were granted to you under these Terms of Use shall automatically expire. After the expiration of your subscription period, you will still be able to access your measurements in the third party application.
Termination for breach. We may terminate with immediate effect these Terms of Use and your right to access and use the FibriCheck Services (i) if we believes or have reasonable grounds to suspect that you are violating these Terms of Use (including but not limited to any violation of our Intellectual Property Rights) or any other guidelines or policies issued by us or (ii) if you remain suspended for non-payment for more than 60 (sixty) days.
Effects of termination. Upon the termination of these Terms of Use for any reason whatsoever in accordance with the provisions of these Terms of Use, at the moment of effective termination: (i) you will no longer be authorized to access or use the FibriCheck Services; (ii) FibriCheck may delete data associated with your Account, including but not limited to User content or your measurements (iii) all rights and obligations of us and you under these Terms of Use shall terminate, except those rights and obligations under those sections specifically designated in Article 15.7.
15. Miscellaneous
15.1 Force Majeure
We shall not be liable for any failure or delay in the performance of our obligations with regard to the FibriCheck Services if such delay or failure is due to causes beyond our control, including by not limited to acts of God, war, strikes or labor disputes, embargoes, government orders, telecommunications, network, computer, server or Internet downtime, unauthorized access to our information technology systems by third parties or any other cause beyond our reasonable control (the "Force Majeure Event"). We shall notify you of the nature of such Force Majeure Event and the effect on our ability to perform our obligations under these Terms of Use and how we plan to mitigate the effect of such Force Majeure Event.
15.2 Entire agreement
These Terms of Use constitute the entire agreement and understanding between you and us with respect to the subject matter hereof and supersedes all prior oral or written agreements, representations or understandings between you and us relating to the subject matter hereof. No statement, representation, warranty, covenant or agreement of any kind not expressly set forth in these Terms of Use shall affect, or be used to interpret, change or restrict, the express terms and provisions of these Terms of Use.
15.3 Severability
If any provision of these Terms of Use are, for any reason, held to be invalid or unenforceable, the other provisions of these Terms of Use will remain enforceable and the invalid or unenforceable provision will be deemed modified so that it is valid and enforceable to the maximum extent permitted by law.
15.4 Waiver
Any failure to enforce any provision of these Terms of Use shall not constitute a waiver thereof or of any other provision.
15.5 Assignment
You may not assign or transfer these Terms of Use or any rights or obligations to any third party. We shall be free to (i) transfer or assign (part of) its obligations or rights under the Terms of Use to one of its affiliates and (ii) to subcontract performance or the support of the performance of this Terms of Use to our affiliates, to individual contractors and to third party service providers without prior notification to you.
15.6 Notices
All notices from us intended for receipt by you shall be deemed delivered and effective when sent to you to your account on the third party application.
15.7 Survival
Articles 9, 10, 12, 14, 15.7, 15.8 shall survive any termination or expiration of this Agreement.
15.8 Governing law and jurisdiction
Without prejudice to any mandatory legislation, these Terms of Use shall be exclusively governed by and construed in accordance with the laws of Belgium, without giving effect to any of its conflict of law principles or rules. The courts and tribunals of Hasselt shall have sole jurisdiction should any dispute arise relating to these Terms of Use.
FibriCheck Service Instructions for Use
Latest revision 17/10/2022
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 application 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 labelling 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.
The confirmation by the healthcare provider is shown as a notification in the notification log in the app.
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