Intended use and indications for use
The intended use is to detect atrial fibrillation in adult population. The target group is adult population. Indication for use is medical professional’s or layman’s suspicion of atrial fibrillation or intention to exclude or detect the existence of possible atrial fibrillation. The Precordior Cardiosignal Application is not intended to be used by persons with known or diagnosed cardiac rhythm disorder other than atrial fibrillation.
Contraindications and restrictions of use
Turned-on phone next to the pacemaker implant may cause electromagnetic interference (EMI) which can result malfunction of the pacemaker. Cardiac pacemakers can also falsify the result of the rhythm analysis. For these reasons cardiac pacemaker wearers should not use the App.
The positive result indicating probable atrial fibrillation needs to be verified by a physician. The app is intended for screening purposes of possible atrial fibrillation and is not intended to be a diagnostic device. The diagnosis is placed by a physician and should occur as medical guidelines recommend, e.g. with 12-lead electrocardiogram recording.
If you have any questions about the Products (as defined hereinafter) or this Agreement, please contact us via firstname.lastname@example.org
PLEASE NOTE THAT YOU ARE NOT OBLIGED TO INSTALL THE APPLICATION AND YOUR REFUSAL TO INSTALL THE APPLICATION DOES NOT HAVE ANY IMPACT ON THE TREATMENT BY YOUR PHYSICIAN OR THE QUALITY OF SUCH TREATMENT. PRECORDIOR EMPHASIZES THAT YOUR PRECORDIOR HEALTH DATA IS YOUR PRIVATE DATA. FOR QUALITY CONTROL AND SERVICE DEVELOPMENT PRECORDIOR MAY ACCESS AND ANALYSE YOUR DATA. YOUR PHYSICIAN DOES NOT HAVE ACCESS TO YOUR DATA UNLESS YOU HAVE SEPARATELY AGREED TO THIS. THEREFORE IT IS SOLELY ON YOUR RESPOSIBILITY TO SEEK MEDICAL ATTENTION FOR THE DETECTED ATRIAL FIBRILLATION. IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY, PLEASE CONTACT YOUR PHYSICIAN OR THE EMERGENCY SERVICES IMMEDIATELY.
The Application is operated and managed by Precordior, a limited company registered in Finland in the address of Itäinen Pitkäkatu 4, 20500, Turku. The company registration number is 2800927-7.
If you have any questions about the Products (as defined hereinafter) or this Agreement, please contact us via email@example.com
1. Description of the application
1.1. Precordior provides Precordior CardioSignal Application, a service which can detect atrial fibrillation, which is the most common cardiac rhythm disorder. Precordior CardioSignal Application consists of the Precordior Cardiosignal Mobile Application ("App") and Precordior CardioSignal Platform ("Platform") cloud system, both referred collectively as the "Application". The Application is intended for personal use only. All analyses are performed in the Platform and the results are sent back to the App. Therefore the App requires an internet connection to function with the Platform. All rhythm analyses and recordings are stored in the Platform. For the Application quality assurance we retain the option to store the data even if you have deleted it from your personal account. All collected data may be used for quality analyses and algorithm optimization development. To gain scientific recognition some analyses from these may be peer reviewed and published. All published data is fully anonymous and recognition of an individual Users form these data is not possible.
1.2. The Precordior CardioSignal App is available in Apple AppStore and Google Play for both iOS and Android operating systems. The App is freely downloadable free of charge. Precordior collects a service fee for the cardiac rhythm detection services, i.e. detection of atrial fibrillation. The Application can be used with collaboration with a third party (e.g. insurance company or health care provider). In this situation please follow the instructions provided to you from this third party. Precordior provides Instruction for Use in the App and in the Precordior website at www.precordior.com.
The Application is available to users in the European and other countries covered by CE regulation.
The recordings via the App are performed by placing the smart phone on your chest on top of your chest bone (sternum). The App reads data from accelerometer and gyroscope which react to the chest movements caused by your heart beats.
Please note that you as the Application user are solely responsible to act based on the results the Application provides. Your physician and or anyone in Precordior cannot be held accountable to react to the results on your behalf. We advise you to seek medical attention without a delay in case of positive recording suggesting probable atrial fibrillation, and also in cases where the App may not show atrial fibrillation but you are not feeling well.
"Account" means your registered account that you have created through the registration process from an official registration channel;
"Delivery Date" means the date on which you obtained an Account;
"Documentation" means the documents made available to the User by Precordior with regard to the use of the Application;
"Fees" means the amount to be paid by the User (if required) to Precordior.
"Precordior Cardiosignal Platform" means the cloud service where all analyses and data are stored ("Platform").
"Intellectual Property Rights" means 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 intellectual 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;
"Products" means the Application, Website and Documentation;
"Results" means the results of the analysis by the Platform based upon data recorded by the User through the Mobile App;
"Third Parties" means any natural or legal person or entity other than Precordior;
"Website" means the website available at www.precodior.com.
3.1. By using the Products, you accept the terms and conditions of the present Agreement. If you disagree with any particular provision in the present Agreement, you are not permitted to use the Products in any shape or form.
3.2. Where the Application or the Website 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. Precordior declines all and any liability for the substance of the terms and conditions of the Third Parties.
With respect to the processing of your Personal data by Third Parties, please see Part 8 of our Privacy Notice.
4. Use of the products
Please note that our Products are not intended and may not be used by individuals under 18 years of age.
4.1. You are permitted to use the Application only by using your own account. The installation of the application is free of charge, however unlocking some features of the app (e.g. measurement) requires purchase of a license.
4.2. In order to use all functionalities of our Application, your mobile device need to access Wi-Fi or mobile Internet and your mobile device must have motion sensors. Your mobile device must have operating system version which is compatible with Application. Access to Wi-Fi or a mobile Internet connection is your own responsibility. Please make sure your mobile device complies with the minimum operating system and possible hardware requirements as specified on the Apple AppStore and Google Play stores' application information page. A list of tested mobile devices is presented on the Precordior webpage.
If your mobile device does not meet these minimum system requirements, we are unable to guarantee that the Application will work properly. Precordior declines all and any liability for loss or damage due to the fact that you failed to comply with the aforesaid requirements.
4.3. You are co-responsible to uphold the confidentiality and security of the login data of your account, such as your pin code and password (see also Part 7 of the Privacy Notice).
You are fully responsible for all activities carried on by you under your individual account.
You accept to immediately notify Precordior of any unauthorized use of your account or of any other security breaches at firstname.lastname@example.org. Precordior declines all and any liability for loss or damage due to the fact that you failed to comply with the aforesaid requirements.
4.4. Precordior may, in its sole discretion, provide you with updates. During your contract term all updates, if any, will be provided to you free of charge. For the avoidance of doubt, Precordior is not obligated to provide any updates to the Application, Documentation or Website.
5. License – restrictions
5.1 License by Precordior. By registering an account to the Application, Precordior grants you a limited, non-exclusive, personal, restricted, non-sub-licensable and non-transferable license to use the Application and/or the Documentation in accordance with this Agreement and the Documentation ("License"). You are not allowed to use the Application and/or the Documentation for any commercial purposes or to use the Application and/or Documentation, or a component of the foregoing in a manner not authorized by Precordior. You shall use the Application and/or the Documentation solely for the purpose set out in this Agreement and the Documentation and in full compliance with (i) this Agreement;(ii) any additional instructions or policies issued by Precordior, including, but not limited to, those posted within the Precordior smart phone Application or on the Website; (iii) any applicable legislation, rules or regulations and (iv) the Documentation.
5.2 Restrictions. You agree to use the Products 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 Application and/or Documentation available or to sell or rent the Application and/or Documentation to any third parties. However, you have the right to make the Application and Documentation available for your healthcare professionals; (ii) adapt, alter, translate or modify in any manner the Application and/or Documentation; (iii) sublicense, lease, rent, loan, distribute, or otherwise transfer the Application and/or 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, algorithms, structure or organization) of the Application, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation. In an event like this Precordior requires a written notification of such process prior the initiation of the process by email to email@example.com; (v) use or copy the Application and/or Documentation except as expressly allowed under this article 6; (vi) gain unauthorized access to accounts of other users or the IT equipment or structure of Precordior to provide the Products or use the Products to conduct or promote any illegal activities; (vi) use the Products to generate unsolicited email advertisements or spam; (vii) impersonate any person or entity, or otherwise misrepresent your affiliation with a person or entity; (viii) use any high volume automatic, electronic or manual process to access, search or harvest information from the Products (including without limitation robots, spiders or scripts); (ix) alter, remove, or obscure any copyright notice, digital watermarks, proprietary legends or other notice included in the Products; (x) intentionally distribute any worms, Trojan horses, corrupted files, or other items of a destructive or deceptive nature or use the Products for any unlawful, invasive, infringing, defamatory or fraudulent purpose; or (xi) remove or in any manner circumvent any technical or other protective measures in the Products.
Except as expressly set forth herein, no express or implied license or right of any kind is granted to you regarding the Products 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 Application.
5.3 License by user. By uploading, creating or otherwise providing information, data or images on or through the Application ("User Content"), and without prejudice to the provisions of our Privacy Notice, you grant Precordior a non-exclusive, royalty-free, worldwide, sub-licensable, transferable, license to use, copy, store, modify, transmit and display User Content to the extent necessary to provide, and maintain and develop the Application. Precordior reserves the right, but is not obliged, to review and remove any User Content which is deemed to be in violation with the provisions of the Agreement or otherwise inappropriate, any rights of third parties or any applicable legislation or regulation.
As between the User and Precordior, all rights, title and ownership in and related to the Products, including without limitation to any designs, inventions, software, materials, researches, reports and documents, preparatory or other material and all worldwide Intellectual Property Rights pertaining thereto, are the exclusive property of Precordior and/or its licensors
All rights in and to the Application and/or Documentation not expressly granted to the User in this Agreement are reserved by Precordior and its licensors. Except as expressly set forth herein, no express or implied license or right of any kind is granted to the User regarding the Application and/or Documentation or any part thereof, including any right to obtain possession of any source code, data or other technical material related to the Application.
7.1 Suspension for breach. If Precordior becomes aware or suspects, in its sole discretion, any violation by you of this Agreement or any other instructions, guidelines or policies (including but not limited to the Privacy Notice) issued by Precordior, then Precordior may suspend or limit your access to the Application. The duration of any suspension by Precordior will be until you have cured the breach which caused such suspension or limitation.
In case you need technical support, you can contact Precordior at firstname.lastname@example.org. Precordior makes all reasonable efforts to respond as quickly as possible to any inquiries of Users.
Our Privacy Notice has more details on how we obtain and process your Personal data. Our Privacy Notice is included as part of the present Agreement for reference purposes.
In consideration for the Application, before you pay any Fees, you will have the opportunity to review and accept the Fees that will be charged. All Fees are non-refundable, to the fullest extent permitted under applicable law.
If you pay any Fees with a credit card, the biller 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.
11.1 By using the Precordior Application the user acknowledges and agrees that the detection of atrial fibrillation by Precordior is currently not considered diagnostic method according to the medical professional guidelines. The accuracy rate of detecting atrial fibrillation with the Application in very high, over 95 % according clinical research*, but can't be considered an absolute measure thus requiring the sole discretion of the user. Therefore Precordior holds no liability on any medical consequences occurring to the users during their contract term. To the maximum extent permitted under applicable law, Precordior's liability arising out of or in connection with the Products under this Agreement whether in contract, warranty, tort or otherwise, shall not exceed the amount paid out under Precordior's compulsory insurance policy at the date on which the applicable liability claim arises. Nothing in this Agreement shall limit or exclude Precordior's liability for (i) gross negligence; (ii) willful misconduct, (iii) fraud or personal injury. *Circulation 2018; 137:1524-1527.
11.2 To the extent legally permitted under applicable law, Precordior shall not be liable to the User 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 Products under this Agreement, including but not limited to any miscalculations, or the use, misuse, or inability to use the Products, regardless of the cause of action or the theory of liability, whether in tort, contract, or otherwise, even if Precordior have been notified of the likelihood of such damages. The limitation in this article 11.2 shall not apply to the obligations of Precordior under article 13 ("Indemnification").
12. Warranties and disclaimers
12.1 By Precordior. EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE 12 AND TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE PRODUCTS AND THE RESULTS ARE PROVIDED "AS IS," AND PRECORDIOR MAKES 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 PRODUCTS, INCLUDING THE RESULTS, (IN WHOLE OR IN PART) OR ANY OTHER PRODUCTS OR SERVICES PROVIDED TO THE USER BY PRECORDIOR. PRECORDIOR DOES NOT WARRANT THAT (i) ALL ERRORS CAN BE CORRECTED, OR THAT ACCESS TO OR OPERATION OF THE PRODUCTS SHALL BE UNINTERRUPTED, SECURE, OR ERROR-FREE, AND (ii) THE INFORMATION, INCLUDING BUT NOT LIMITED TO THE RESULTS, AVAILABLE ON OR TRANSMITTED BY THE APPLICATION IS TRUE, COMPLETE OR ACCURATE. YOU SPECIFICALLY ACKNOWLEDGE AND AGREE THAT PRECORDIOR CANNOT BE HELD LIABLE FOR ANY HEALTHCARE OR RELATED DECISIONS MADE BY YOU OR YOUR PHYSICIAN BASED UPON THE RESULTS TRANSMITTED OR DISPLAYED BY OR ON THE APPLICATION WHETHER SUCH DATA IS ACCURATE OR INACCURATE. YOU ACKNOWLEDGE AND AGREE THAT YOUR PHYSICIAN, AND NOT PRECORDIOR, IS SOLELY RESPONSIBLE FOR THE INTERPRETATION OF THE RESULTS OR OTHER HEALTHCARE INFORMATION RELATED TO YOU. YOU EXPRESSLY ACKNOWLEDGE AND AGREE THAT YOUR USE OF THE PRODUCTS AND THE RESULTS 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 PRECORDIOR IS NOT RESPONSIBLE FOR ANY LOSSES OF YOUR DATA, INCLUDING BUT NOT LIMITED TO THE RESULTS.
12.2 By User. You represent and warrant to Precordior that 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 Application 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 Precordior's system or data; or (v) otherwise violate the rights of a third party.
You agree that any use of the Application or Documentation contrary to or in violation of the representations and warranties of User in this article constitutes unauthorized and improper use of the Application and/or Documentation.
13.1 By Precordior. Precordior 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 Application and/or Documentation and excluding any claims resulting from (i) your unauthorized use of the Products, (ii) your or any third party's modification of any of the Products, (iii) your failure to use the most recent version of the Application and/or Documentation made available to you, or your failure to install any corrections or updates to such Application and/or Documentation issued by Precordior, if Precordior indicated that such update or correction was required to prevent a potential infringement, or (iv) your use of the Application and/or Documentation in combination with any non-Precordior products or services.
Such indemnity obligation shall be conditional upon the following: (i) Precordior is given prompt written notice of any such claim; (ii) Precordior is granted sole control of the defense and settlement of such a claim; (iii) upon Precordior's request, the User fully cooperates with Precordior in the defense and settlement of such a claim, at Precordior's expense; and (iv) the User makes no admission as to Precordior's liability in respect of such a claim, nor does the User agree to any settlement in respect of such a claim without Precordior's prior written consent. Provided these conditions are met, Precordior shall indemnify the User for all damages and costs incurred by the User as a result of such a claim, as awarded by a competent court of final instance, or as agreed to by Precordior pursuant to a settlement agreement.
In the event the Application and/or Documentation, in Precordior's reasonable opinion, are likely to or become the subject of a third-party infringement claim (as per this clause 13.1), Precordior shall have the right, at its sole option and expense, to: (i) modify the ((allegedly) infringing part of the) Application and/or Documentation so that they become non- infringing while preserving equivalent functionality; (ii) obtain for the User a license to continue using the Application and/or Documentation in accordance with this Agreement; or (iii) terminate the Agreement and pay to the User an amount equal to a pro rata portion of the Fees for that portion of the Application which is the subject of such infringement.
The foregoing states the entire liability and obligation of Precordior and the sole remedy of the User with respect to any infringement or alleged infringement of any Intellectual Property Rights caused by the Application and/or Documentation or any part thereof.
13.2 By User. You hereby agree to indemnify and hold harmless Precordior and its current and future affiliates, officers, directors, employees, agents and representatives from each and every demand, claim, proceeding, actions, loss, liability, or damage of any kind whatsoever, including reasonable attorney's fees, whether in tort or in contract, that it or any of them may incur by reason of, or arising out of, or incurred due to such claim any claim which is made by any third party with respect to (i) any breach or violation by you of any provisions of this Agreement or any other instructions or policies issued by Precordior; (ii) any User Content violating any Intellectual Property Rights of a third party and (iii) fraud, intentional misconduct, or gross negligence committed by you, whether such claim was justified or not.
14. Term and termination
14.1 Precordior shall grant you a license on the Application and/or Documentation for the agreement term unless the Agreement is terminated in accordance with articles 14.2 or 14.3. The User will be eligible to receive all major and minor updates and upgrades for the Application and/or Documentation during the agreement term.
14.2 Termination for breach. Precordior may terminate with immediate effect this Agreement and your right to access and use the Application (i) if Precordior believes or has reasonable grounds to suspect that you are violating this Agreement (including but not limited to any violation of the Intellectual Property Rights of Precordior) or any other guidelines or policies (including but not limited to the Privacy Notice) issued by Precordior or (ii) if the User remains suspended for non-payment for more than 60 (sixty) days.
14.3 Effects of termination. Upon the termination of this Agreement for any reason whatsoever in accordance with the provisions of this Agreement, at the moment of effective termination: (i) you will no longer be authorized to access or use the Application or otherwise use any of the features or Results offered by or through the Application; (ii) Precordior may delete data associated with your account after one year of contract termination, including but not limited to User content or the Results, on the Application and (iii) all rights and obligations of Precordior or User under this Agreement shall terminate, except those rights and obligations under those sections specifically designated in article 15.7.
15.1 Force Majeure. Precordior shall not be liable for any failure or delay in the performance of its obligations with regard to the Application if such delay or failure is due to causes beyond our control due 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 Precordior's information technology systems by third parties or any other cause beyond the reasonable control of Precordior (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 this Agreement and how we plan to mitigate the effect of such Force Majeure Event.
15.2 Entire agreement. This Agreement (including the Privacy Notice) constitutes the entire agreement and understanding between you and Precordior with respect to the subject matter hereof and supersedes all prior oral or written agreements, representations or understandings between the Parties relating to the subject matter hereof. No statement, representation, warranty, covenant or agreement of any kind not expressly set forth in this Agreement shall affect, or be used to interpret, change or restrict, the express terms and provisions of this Agreement.
15.3 Severability. If any provision of this Agreement is, for any reason, held to be invalid or unenforceable, the other provisions of this Agreement 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 the Agreement shall not constitute a waiver thereof or of any other provision.
15.5 Assignment. You may not assign or transfer this Agreement or any rights or obligations to any third party. Precordior shall be free to (i) transfer or assign (part of) its obligations or rights under the Agreement to one of its affiliates and (ii) to subcontract performance or the support of the performance of this Agreement to its affiliates, to individual contractors and to third party service providers without prior notification to the User.
15.6 Notices. All notices from Precordior intended for receipt by you shall be deemed delivered and effective when sent to the email address provided by you on your Account. If you change this email address, you must update your email address on your Precordior application.
15.7 Survival. Articles 7, 11, 12, 14, 15.8 shall survive any termination or expiration of this Agreement.
15.8 Governing law and jurisdiction. Without prejudice to any mandatory legislation, this Agreement shall be exclusively governed by and construed in accordance with the laws of Finland, without giving effect to any of its conflict of law principles or rules. The courts and tribunals of Finland shall have sole jurisdiction should any dispute arise relating to this Agreement.
This document was updated