Legal

Terms & Conditions

Cardiosense, Inc.
Version: Draft 1.0
Last Updated: October 5, 2026

1. Acceptance of these Terms & Conditions

These Terms & Conditions (“Terms”) constitute a legally binding agreement between you and Cardiosense, Inc. (“Cardiosense,” “Company,” “we,” “our,” or “us”) governing your access to and use of the Cardiosense websites, mobile applications, cloud services, connected medical devices, software, APIs, dashboards, reports, and related products and services (collectively, the “Services”).

By accessing or using any portion of the Services, creating an account, downloading software, connecting a Cardiosense device, or otherwise using the Services, you acknowledge that you have read, understood, and agree to be bound by these Terms.

If you do not agree to these Terms, you must immediately discontinue use of the Services.

Certain Services may be subject to additional agreements, including subscription agreements, business associate agreements, software license agreements, purchase agreements, or professional services agreements. Where such agreements expressly conflict with these Terms, the specific agreement shall govern solely with respect to the applicable Service.

2. Definitions

For purposes of these Terms, the following definitions apply:

Account means a registered user account created to access one or more Services.

Administrator means an individual authorized by an organization to manage user accounts and system settings.

Authorized User means an individual authorized by Cardiosense or by a customer organization to access the Services.

Applicable Law means all applicable federal, state, local, and international statutes, regulations, rules, guidance documents, court orders, and governmental requirements.

Cardiosense Device means any hardware manufactured, distributed, or authorized by Cardiosense for use with the Services.

Clinical Data means physiological measurements, ECG recordings, PPG recordings, patient-generated health information, device-generated information, and associated metadata.

Content means software, text, graphics, documentation, images, reports, databases, audiovisual materials, trademarks, logos, and other information made available through the Services.

Healthcare Professional means a physician or other licensed healthcare provider authorized under Applicable Law to provide clinical care.

Mobile Application means any software application provided by Cardiosense for installation on a smartphone, tablet, wearable device, or similar computing platform.

Personal Information shall have the meaning provided under Applicable Law.

Protected Health Information (PHI) shall have the meaning assigned under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), where applicable.

Services means collectively the websites, software, cloud platform, mobile applications, APIs, connected medical devices, reports, analytics, dashboards, technical support, and related services provided by Cardiosense.

Software means all firmware, embedded software, mobile software, cloud software, web applications, algorithms, analytics, documentation, and updates provided by Cardiosense.

User Content means information uploaded, entered, transmitted, or otherwise provided by a user through the Services.

3. Eligibility and Authorized Users

The Services are intended for use only by individuals who possess the legal capacity to enter into binding contracts under Applicable Law.

Where the Services are intended for healthcare professionals, only appropriately licensed professionals acting within the scope of their licensure may use those portions of the Services designated for clinical use.

Organizations purchasing or licensing the Services are responsible for ensuring that all Authorized Users receive appropriate training regarding the proper operation of the Services.

Users are responsible for maintaining the confidentiality of account credentials and for all activities occurring under their accounts.

Cardiosense reserves the right to refuse registration, suspend accounts, or revoke access where necessary to protect patient safety, system security, regulatory compliance, or the integrity of the Services.

4. General Conditions of Use

Users agree to use the Services solely for lawful purposes and in accordance with these Terms, the applicable product labeling, user manuals, instructions for use, and all Applicable Laws.

Users shall not rely upon the Services beyond their documented intended use or regulatory authorization.

Access to the Services does not transfer ownership of any intellectual property rights.

Cardiosense reserves the right to monitor system performance, maintain audit logs, implement cybersecurity safeguards, perform maintenance, and temporarily suspend access where reasonably necessary to maintain system integrity or comply with legal obligations.

Nothing contained within these Terms shall be interpreted as creating any physician-patient relationship, fiduciary relationship, agency relationship, or partnership between Cardiosense and any user.

5. Scope of the Services

Cardiosense provides an integrated platform consisting of one or more medical devices, mobile software applications, cloud-based software, web portals, application programming interfaces (“APIs”), analytical tools, technical documentation, and related services designed to support the collection, transmission, storage, visualization, and analysis of physiological data.

The specific functionality available to a user depends upon the products licensed or purchased, regulatory authorizations applicable within the user’s jurisdiction, system configuration, user role, and any applicable service agreement.

Cardiosense may modify, enhance, discontinue, or replace features of the Services from time to time in order to improve functionality, maintain cybersecurity, comply with regulatory requirements, or address technical issues. Cardiosense will use reasonable efforts to provide advance notice of material changes where practicable.

Certain features may require compatible hardware, software, internet connectivity, mobile devices, wireless communication services, third-party software, or subscription services. Cardiosense does not guarantee the continued availability or compatibility of third-party products or services.

6. Intended Use of the Services

The Services shall be used solely in accordance with:

the applicable product labeling;
the applicable Instructions for Use;
any operating manuals provided by Cardiosense;
the intended use authorized or cleared by applicable regulatory authorities; and
Applicable Law.

Users shall not use any Cardiosense product for purposes that are inconsistent with its documented intended use or regulatory authorization.

No statement contained within the Services shall expand, modify, or replace the intended use set forth in the applicable product labeling.

Users acknowledge that improper installation, misuse, unauthorized modification, operation outside specified environmental conditions, failure to follow operating instructions, or use with incompatible equipment may adversely affect device performance.

7. Regulatory Status

Certain Cardiosense products constitute medical devices regulated by governmental authorities, including the U.S. Food and Drug Administration (“FDA”) and regulatory authorities in other jurisdictions.

Unless expressly stated otherwise in the applicable product labeling or regulatory documentation, no statement made through the Services shall be interpreted as:

expanding the indications for use of a Cardiosense product;
creating new clinical claims;
authorizing off-label use;
constituting medical advice; or
representing that a product has received regulatory clearance, approval, certification, or authorization beyond that expressly identified by Cardiosense.

Features identified by Cardiosense as investigational, research use only, evaluation versions, beta features, prototype functionality, or similar designations are not intended for clinical decision-making unless expressly authorized in writing by Cardiosense.

Nothing contained within the Services shall be interpreted as guaranteeing reimbursement, regulatory approval, certification, or market authorization in any jurisdiction.

Users remain responsible for ensuring compliance with all Applicable Laws governing the use of medical devices within their jurisdiction.

8. Medical Disclaimer

The Services are intended to assist qualified users by facilitating the collection, processing, organization, display, and communication of physiological information.

The Services are not intended to replace the independent medical judgment, skill, knowledge, or professional responsibility of licensed healthcare professionals.

Healthcare professionals remain solely responsible for:

evaluating each patient;
reviewing all available clinical information;
interpreting diagnostic findings;
determining the appropriate diagnosis;
determining appropriate treatment;
monitoring patient status; and
exercising independent clinical judgment.

Patients should never disregard professional medical advice or delay seeking medical care because of information generated through the Services.

Cardiosense does not practice medicine, provide medical services, diagnose disease, prescribe treatment, or establish physician-patient relationships through the Services.

No information provided through the Services shall be construed as legal, medical, or professional advice.

9. Clinical Decision-Making

Where the Services generate measurements, notifications, reports, trends, scores, analytics, classifications, alerts, or recommendations, such outputs are intended solely to support—not replace—the clinical assessment performed by qualified healthcare professionals.

Clinical decisions shall not be based exclusively upon software-generated outputs.

Users acknowledge that physiological measurements may be affected by numerous factors, including but not limited to:

patient movement;
improper sensor placement;
poor skin contact;
software configuration;
hardware condition; and
user error.

Accordingly, software-generated outputs should always be interpreted within the broader clinical context.

10. No Emergency Use

THE SERVICES ARE NOT INTENDED TO BE USED AS AN EMERGENCY RESPONSE SYSTEM.

Unless expressly identified by Cardiosense in applicable product labeling, the Services are not designed to summon emergency medical services, dispatch emergency personnel, provide continuous life-sustaining monitoring, or guarantee immediate notification of clinically significant events.

Users should not rely upon the Services during medical emergencies.

If a user believes that a patient is experiencing a medical emergency, the user should immediately contact local emergency medical services or proceed to the nearest emergency medical facility.

Transmission delays, wireless interruptions, internet outages, equipment failures, power interruptions, maintenance activities, software updates, cybersecurity events, or third-party service interruptions may delay or prevent notifications, data transmission, or report availability.

Cardiosense disclaims responsibility for damages resulting from reliance upon delayed, interrupted, incomplete, or unavailable communications.

11. Device Performance Limitations

Users acknowledge that no medical device is capable of detecting every clinically significant event or producing accurate results under all operating conditions.

Device performance depends upon numerous variables, including proper installation, patient physiology, compatible accessories, network connectivity, and user compliance with operating instructions.

Cardiosense does not warrant uninterrupted operation, uninterrupted data transmission, continuous wireless connectivity, or error-free performance.

Users are responsible for reviewing applicable product labeling to understand the operating limitations, contraindications, precautions, warnings, and performance characteristics of each Cardiosense product.

12. Software Improvements and Regulatory Changes

Cardiosense continually improves its products to enhance safety, cybersecurity, usability, performance, and regulatory compliance.

Accordingly, Cardiosense may deploy software updates, firmware updates, algorithm improvements, cybersecurity patches, configuration changes, and feature enhancements.

Some updates may be mandatory to maintain regulatory compliance or cybersecurity.

Failure to install required updates may limit functionality, reduce compatibility, affect technical support eligibility, or result in suspension of certain Services where necessary to protect patient safety or system security.

Nothing contained within these Terms obligates Cardiosense to maintain legacy functionality indefinitely where modification is necessary to comply with Applicable Law, cybersecurity requirements, or evolving regulatory expectations.

13. User Accounts

Certain Services may require the creation of a user account. Users agree to provide accurate, complete, and current registration information and to promptly update such information if it changes.

Each account is personal to the authorized user unless otherwise expressly permitted by Cardiosense. Users shall not share login credentials, permit unauthorized individuals to access the Services through their accounts, or otherwise compromise the security of account credentials.

Users are solely responsible for all activities occurring under their accounts, whether authorized or unauthorized, unless resulting directly from Cardiosense’s failure to implement commercially reasonable security measures.

Users shall immediately notify Cardiosense of any suspected unauthorized access, credential compromise, cybersecurity incident, or unauthorized use of an account.

Cardiosense reserves the right to suspend, disable, or terminate accounts where necessary to protect patient safety, system integrity, cybersecurity, intellectual property, or compliance with Applicable Law.

14. License Grant

Subject to these Terms and any applicable commercial agreement, Cardiosense grants the user a limited, revocable, non-exclusive, non-transferable, non-sublicensable license to access and use the Services solely for their intended purpose.

Except as expressly authorized by Cardiosense in writing, users shall not:

copy the Software except as necessary for authorized use;
modify or create derivative works;
distribute, lease, rent, sublicense, or resell the Services;
reverse engineer, decompile, disassemble, or otherwise attempt to derive source code except where such restrictions are prohibited by Applicable Law;
circumvent security mechanisms or technological protection measures;
remove copyright notices or proprietary markings;
use the Services to develop competing products or services;
access the Services for benchmarking or competitive analysis without prior written authorization.

No ownership interest is transferred by this license.

All rights not expressly granted remain reserved by Cardiosense.

15. Software Updates

Cardiosense may provide software updates, firmware updates, security patches, algorithm modifications, bug fixes, usability improvements, and feature enhancements.

Users acknowledge that updates may:

improve performance;
address cybersecurity vulnerabilities;
correct software defects;
comply with regulatory requirements;
improve compatibility;
retire obsolete functionality.

Certain updates may be installed automatically where permitted by Applicable Law.

Users may be required to install mandatory updates before continued access to certain Services.

Failure to install required updates may affect product performance, compatibility, cybersecurity, technical support eligibility, or regulatory compliance.

16. Device Compatibility

Certain Services require compatible hardware, operating systems, browsers, mobile devices, wireless communication technologies, accessories, or network infrastructure.

Cardiosense does not warrant compatibility with every third-party product.

Users are responsible for maintaining compatible equipment meeting the minimum published system requirements.

Cardiosense may periodically revise compatibility requirements to improve safety, cybersecurity, or performance.

Unsupported operating systems, obsolete browsers, rooted or jailbroken mobile devices, unauthorized accessories, or modified hardware may prevent proper operation of the Services.

17. Technical Support

Technical support is provided only for supported products and supported software versions unless otherwise agreed in writing.

Cardiosense may require users to install current software releases before providing technical support.

Support availability, response times, maintenance windows, and service levels are governed by any applicable subscription agreement, service agreement, or support contract.

Cardiosense may temporarily suspend portions of the Services during scheduled maintenance, emergency maintenance, cybersecurity events, infrastructure upgrades, or regulatory activities.

Cardiosense shall use reasonable efforts to minimize planned service interruptions.

18. Third-Party Products and Services

The Services may interoperate with products, applications, cloud platforms, communication networks, operating systems, browsers, electronic health record systems, wearable devices, or other products provided by third parties.

Cardiosense neither owns nor controls such third-party products unless expressly identified otherwise.

Availability and performance of third-party services remain the responsibility of the applicable third-party provider.

Cardiosense shall not be responsible for:

third-party outages;
discontinued integrations;
changes to third-party APIs;
wireless carrier interruptions;
internet service failures;
cloud provider outages;
delays caused by external systems.

Users are responsible for complying with applicable third-party license agreements and terms of service.

19. Subscription Services

Certain Services may be offered pursuant to subscription plans.

Subscription terms, pricing, renewal periods, payment obligations, and cancellation rights shall be governed by the applicable commercial agreement, order form, or subscription agreement.

Unless otherwise expressly stated, subscriptions grant only a limited right to access the Services during the subscription term and do not transfer ownership of any software or intellectual property.

Failure to timely pay applicable fees may result in suspension or termination of access after any required notice period.

20. User Responsibilities

Users agree to use the Services responsibly and in accordance with all Applicable Laws.

Users are responsible for:

maintaining appropriate cybersecurity safeguards;
protecting passwords and authentication credentials;
ensuring proper operation of compatible equipment;
following Instructions for Use;
maintaining internet connectivity where required;
installing required software updates;
promptly reporting suspected malfunctions;
reviewing system notifications in a timely manner.

Healthcare organizations remain responsible for their own clinical workflows, staffing decisions, medical record documentation, and patient care processes.

Nothing within the Services replaces organizational policies or professional standards governing clinical practice.

21. Acceptable Use

Users shall use the Services only for lawful purposes and only in the manner authorized by Cardiosense.

Users shall not knowingly interfere with the operation, availability, integrity, confidentiality, or security of the Services.

Users shall cooperate with reasonable requests made by Cardiosense to investigate cybersecurity incidents, fraud, misuse, regulatory inquiries, or system integrity concerns.

22. Prohibited Conduct

Without limiting any other provision of these Terms, users shall not:

use the Services for unlawful purposes;
upload malicious software or harmful code;
attempt unauthorized access to systems or data;
interfere with cybersecurity controls;
overload or disrupt network infrastructure;
circumvent authentication mechanisms;
impersonate another person;
falsify patient or account information;
violate export control laws;
use automated tools to scrape or harvest information without authorization;
exploit vulnerabilities;
distribute malware;
perform denial-of-service attacks;
transmit unlawful, defamatory, infringing, or fraudulent content;
use the Services in a manner inconsistent with the applicable Instructions for Use.

Violation of this Section may result in immediate suspension or termination of access and may be reported to applicable governmental authorities where required by law.

23. Audit and Security Monitoring

To protect patient safety, system integrity, and regulatory compliance, Cardiosense may maintain audit logs documenting user authentication, system access, software events, security events, administrative actions, and other operational activities.

Users acknowledge that such monitoring is intended solely for legitimate business, regulatory, quality, and cybersecurity purposes.

Where permitted by Applicable Law, Cardiosense may investigate suspected misuse, security incidents, or violations of these Terms and may preserve relevant records as required by law or legal process.

24. Privacy and Data Processing

Cardiosense is committed to protecting the privacy and security of information processed through the Services.

The collection, use, disclosure, storage, retention, and protection of Personal Information are governed by these Terms, the Cardiosense Privacy Policy, and Applicable Law.

By using the Services, users acknowledge that Cardiosense may collect and process information necessary to:

provide the Services;
authenticate users;
operate connected devices;
maintain cybersecurity;
improve system performance;
respond to technical support requests;
comply with legal and regulatory obligations;
perform quality management activities;
investigate suspected misuse or security incidents.

Where Applicable Law requires consent for particular processing activities, Cardiosense will obtain such consent directly or through the applicable healthcare provider or customer organization, as appropriate.

Cardiosense processes information only for legitimate business, regulatory, contractual, clinical support, or legal purposes consistent with Applicable Law.

25. Protected Health Information (HIPAA)

To the extent Cardiosense receives, maintains, creates, or transmits Protected Health Information (“PHI”) on behalf of a Covered Entity or Business Associate, the parties shall comply with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their implementing regulations.

Where required by HIPAA, the parties shall execute a separate Business Associate Agreement (“BAA”), which shall govern the handling of PHI in the event of any conflict with these Terms.

Nothing in these Terms shall be construed as modifying obligations established by an executed Business Associate Agreement.

Users remain responsible for determining whether HIPAA applies to their activities and for complying with all applicable privacy and security requirements.

26. Customer Data

As between Cardiosense and the customer, the customer retains ownership of Customer Data submitted to the Services.

Except as permitted by these Terms, Applicable Law, or the applicable commercial agreement, Cardiosense does not acquire ownership of Customer Data solely because such information is stored or processed using the Services.

Cardiosense receives only the limited rights necessary to:

host the data;
process the data;
transmit the data;
display the data;
back up the data;
secure the data;
troubleshoot technical issues;
provide customer support;
improve the operation of the Services where permitted by Applicable Law and contract.

Cardiosense shall not sell identifiable patient information except where expressly authorized by Applicable Law or by the applicable data subject.

Users may request access to, correction of, or deletion of their personal information by contacting Cardiosense.

27. User Content

Users remain solely responsible for the accuracy, completeness, legality, and appropriateness of User Content submitted through the Services.

Users represent and warrant that they possess all rights necessary to submit such information.

Users shall not upload information that:

infringes intellectual property rights;
violates privacy rights;
contains malicious software;
violates Applicable Law;
contains fraudulent information;
exceeds the authorized purpose of the Services.

Cardiosense reserves the right to remove or restrict access to User Content where reasonably necessary to protect patient safety, comply with Applicable Law, investigate suspected misconduct, or maintain system integrity.

28. De-Identified and Aggregated Data

To the extent permitted by Applicable Law and any applicable contractual restrictions, Cardiosense may create, use, disclose, analyze, and retain de-identified, anonymized, or aggregated information derived from Customer Data.

Such information shall not reasonably identify any individual patient.

Cardiosense may use de-identified information for purposes including:

quality management;
software validation;
cybersecurity;
system performance monitoring;
regulatory compliance;
product improvement;
statistical analysis;
scientific research;
publication of aggregate statistics.

Cardiosense shall not attempt to re-identify properly de-identified information except where required by Applicable Law or necessary to investigate security incidents or product safety concerns.

29. Data Security

Cardiosense maintains administrative, physical, and technical safeguards designed to protect information processed through the Services against unauthorized access, disclosure, alteration, or destruction.

Such safeguards may include:

encryption of data in transit using industry-standard protocols;
encryption of stored data where appropriate;
access controls based upon user roles;
authentication mechanisms;
audit logging;
vulnerability management;
security monitoring;
malware protection;
disaster recovery measures;
business continuity planning.

No information system is completely secure.

Accordingly, Cardiosense does not guarantee that unauthorized access, cybersecurity incidents, or security breaches will never occur.

Users are responsible for maintaining the security of their own computing environments, including endpoint protection, network security, password management, and physical security of devices.

30. Data Retention

Cardiosense retains information only for so long as reasonably necessary to:

provide the Services;
satisfy contractual obligations;
comply with Applicable Law;
support regulatory requirements;
resolve disputes;
enforce agreements;
maintain quality system records;
investigate product safety concerns.

Retention periods may differ depending upon the type of information involved and applicable regulatory requirements.

Upon expiration or termination of applicable agreements, Customer Data may be deleted, returned, archived, or retained as required by Applicable Law, contractual obligations, litigation holds, or regulatory record retention requirements.

31. International Data Transfers

Where Customer Data is transferred across national borders, Cardiosense shall implement appropriate safeguards required by Applicable Law.

Users acknowledge that information may be processed in jurisdictions different from the jurisdiction in which it was originally collected.

Where required, Cardiosense shall implement contractual safeguards or other legally recognized transfer mechanisms.

32. Confidentiality

Users may receive access to confidential or proprietary information belonging to Cardiosense, including software, technical documentation, product designs, algorithms, security procedures, pricing information, business plans, and non-public technical information (“Confidential Information”).

Users agree to:

protect Confidential Information using reasonable care;
use Confidential Information solely for authorized purposes;
restrict disclosure to authorized individuals having a legitimate need to know;
promptly notify Cardiosense of unauthorized disclosure.

Confidential Information does not include information that:

becomes publicly available without breach of these Terms;
was lawfully known before disclosure;
is independently developed without reference to Confidential Information; or
is lawfully obtained from a third party without confidentiality restrictions.

33. Cybersecurity Responsibilities

Because the Services include connected medical technologies, cybersecurity is a shared responsibility between Cardiosense and its customers.

Users agree to:

install software updates promptly;
maintain supported operating systems;
implement reasonable password policies;
restrict unauthorized physical access;
promptly report suspected cybersecurity incidents;
follow Cardiosense security guidance;
avoid connecting unsupported or compromised devices.

Failure to implement reasonable cybersecurity measures may adversely affect device performance, compromise patient information, or reduce the effectiveness of technical support.

34. Incident Reporting

Users shall promptly notify Cardiosense upon becoming aware of:

suspected cybersecurity incidents affecting the Services;
unauthorized system access;
malware infections involving Cardiosense products;
suspected product malfunctions affecting patient safety;
unauthorized disclosure of sensitive information;
security vulnerabilities involving Cardiosense products.

Cardiosense may investigate reported incidents, implement corrective actions, deploy security updates, cooperate with governmental authorities where required by law, and notify affected customers consistent with Applicable Law and contractual obligations.

35. Intellectual Property Rights

The Services, including all Software, Cardiosense devices, documentation, algorithms, user interfaces, workflows, reports, dashboards, graphics, text, audiovisual materials, source code, object code, firmware, databases, APIs, technical information, and all improvements thereto (collectively, the “Cardiosense Intellectual Property”), are owned by or licensed to Cardiosense and are protected by United States and international intellectual property laws.

Except for the limited license expressly granted under these Terms, no right, title, or interest in any Cardiosense Intellectual Property is transferred to any user.

Users shall not acquire any ownership interest through use of the Services.

Nothing contained in these Terms shall be interpreted as granting any implied license or other rights beyond those expressly stated herein.

36. Trademarks

The names Cardiosense, the Cardiosense logo, product names, service names, slogans, graphics, and other marks used in connection with the Services are trademarks or service marks owned by Cardiosense or its licensors.

Users shall not use Cardiosense trademarks without the Company’s prior written consent except as necessary to accurately identify Cardiosense products in accordance with applicable trademark law.

Nothing contained within these Terms grants any license to use Cardiosense trademarks.

37. Copyright

All Content made available through the Services is protected by copyright and other intellectual property laws.

Except as expressly authorized by Cardiosense, users shall not:

reproduce;
distribute;
publicly display;
publicly perform;
publish;
transmit;
modify; or
create derivative works from

any portion of the Services or Content.

Reasonable internal copies of documentation may be made solely for authorized internal business purposes unless otherwise prohibited by Cardiosense.

38. Feedback

Cardiosense welcomes suggestions regarding improvements to the Services.

If a user voluntarily provides suggestions, comments, ideas, enhancement requests, corrections, or other feedback (“Feedback”), the user grants Cardiosense a perpetual, worldwide, irrevocable, royalty-free, fully paid, transferable, sublicensable license to use, modify, reproduce, distribute, display, perform, create derivative works from, and otherwise use such Feedback without restriction or compensation.

Users represent that they possess sufficient rights to provide such Feedback.

Cardiosense has no obligation to implement any Feedback.

39. User Submissions

Except for Customer Data addressed elsewhere in these Terms, any non-confidential information voluntarily submitted to Cardiosense may be used by Cardiosense for lawful business purposes.

Users should not submit confidential business information unless expressly requested by Cardiosense under an appropriate confidentiality agreement.

40. Open Source Software

Certain components of the Software may incorporate software distributed under open-source or similar licenses.

Such components remain subject to their respective license terms.

Nothing in these Terms limits rights granted under applicable open-source licenses.

Upon written request, Cardiosense will make available information regarding applicable open-source software licenses where required by the relevant license.

41. Artificial Intelligence and Algorithms

Certain Services may utilize statistical models, machine learning, artificial intelligence, signal processing, predictive analytics, or other computational methods to assist users in organizing, analyzing, or presenting physiological information.

Unless expressly stated otherwise in the applicable product labeling, such functionality is intended solely to assist qualified users and is not intended to replace independent clinical judgment.

Algorithmic outputs may include:

measurements;
classifications;
other analytical results.

Algorithmic outputs may be affected by data quality, patient-specific factors, hardware performance, environmental conditions, software configuration, incomplete information, and other variables.

Users remain solely responsible for independently evaluating all clinically relevant information before making medical decisions.

Nothing contained within these Terms guarantees the accuracy, completeness, sensitivity, specificity, predictive value, or clinical utility of algorithmic outputs beyond any performance characteristics expressly described in the applicable product labeling.

42. Research Use

Where authorized by separate written agreement, Cardiosense may participate in research activities involving Customer Data.

Unless otherwise agreed in writing, participation in research shall remain subject to all applicable ethical requirements, institutional approvals, informed consent requirements, and Applicable Law.

Nothing contained in these Terms independently authorizes the use of identifiable patient information for research.

43. Publicity

Neither party shall use the other party’s name, trademarks, service marks, logos, or trade names in advertising, press releases, promotional materials, or public announcements without prior written consent, except as required by Applicable Law or applicable securities regulations.

Cardiosense may identify a customer as a customer in general customer lists unless prohibited by a separate written agreement.

44. Export Compliance

Users agree to comply with all applicable export control, import control, trade sanctions, customs, and anti-boycott laws and regulations, including those administered by the United States Department of Commerce, the United States Department of the Treasury’s Office of Foreign Assets Control (“OFAC”), and other applicable governmental authorities.

Users represent that they are not located in, organized under the laws of, or ordinarily resident in any country or territory subject to comprehensive trade sanctions that prohibit use of the Services, except where authorized by Applicable Law.

Users shall not export, re-export, transfer, or provide access to the Services in violation of Applicable Law.

45. U.S. Government Rights

If the Services are acquired by or on behalf of the United States Government, the software and accompanying documentation constitute “commercial computer software” and “commercial computer software documentation” as those terms are defined under applicable federal acquisition regulations.

The Government’s rights are limited to those expressly provided in these Terms unless otherwise required by mandatory federal law.

46. Digital Millennium Copyright Act

Cardiosense respects the intellectual property rights of others.

If any person believes that material made available through the Services infringes a valid copyright, that person may submit a written notification to Cardiosense’s designated copyright agent containing the information required by the Digital Millennium Copyright Act (“DMCA”), 17 U.S.C. § 512.

Upon receipt of a compliant notice, Cardiosense may remove or disable access to the allegedly infringing material and take such additional actions as permitted by Applicable Law.

Users who repeatedly infringe intellectual property rights may have their access suspended or terminated.

47. Reservation of Rights

Cardiosense expressly reserves all rights not expressly granted under these Terms.

No waiver of any intellectual property right shall be implied through use of the Services, course of dealing, or failure to enforce any provision of these Terms.

Users acknowledge that Cardiosense’s proprietary technology, software architecture, algorithms, cybersecurity controls, product designs, documentation, and business methods constitute valuable trade secrets and confidential commercial information.

Unauthorized use of such information may result in irreparable harm for which monetary damages may be inadequate.

Cardiosense reserves the right to seek injunctive relief and any other remedies available at law or in equity to protect its intellectual property and confidential information.

48. Disclaimer of Warranties

EXCEPT AS EXPRESSLY PROVIDED IN A SEPARATE WRITTEN AGREEMENT SIGNED BY CARDIOSENSE, AND TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE SERVICES, SOFTWARE, CARDIOSENSE DEVICES, DOCUMENTATION, REPORTS, ANALYTICS, AND ALL RELATED CONTENT ARE PROVIDED “AS IS” AND “AS AVAILABLE.”

CARDIOSENSE DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, QUIET ENJOYMENT, OR THOSE ARISING FROM COURSE OF DEALING OR USAGE OF TRADE.

Cardiosense does not warrant that:

the Services will be uninterrupted or error-free;
every software defect can or will be corrected;
communications networks will always be available;
data transmissions will occur without delay;
the Services will be compatible with every third-party product;
every clinically significant event will be detected;
reports or notifications will always be complete, timely, or accurate.

Nothing in this Section limits any warranty that cannot legally be disclaimed under Applicable Law.

49. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, CARDIOSENSE, ITS AFFILIATES, LICENSORS, OFFICERS, DIRECTORS, EMPLOYEES, CONTRACTORS, AND AGENTS SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, EXEMPLARY, OR PUNITIVE DAMAGES, INCLUDING LOSS OF PROFITS, LOSS OF REVENUE, LOSS OF BUSINESS OPPORTUNITY, LOSS OF GOODWILL, LOSS OF DATA, BUSINESS INTERRUPTION, OR COST OF SUBSTITUTE TECHNOLOGY, ARISING OUT OF OR RELATING TO THE SERVICES, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

Except for liability that cannot legally be limited, Cardiosense’s aggregate liability arising from or relating to these Terms shall not exceed the greater of:

the fees paid by the claimant to Cardiosense for the applicable Services during the twelve (12) months immediately preceding the event giving rise to the claim; or
one hundred U.S. dollars (US $100), where no fees have been paid.

The limitations contained in this Section apply regardless of the legal theory asserted, including contract, tort, negligence, strict liability, statutory claims, or otherwise.

Nothing contained herein excludes liability for fraud, willful misconduct, or any liability that cannot legally be excluded under Applicable Law.

50. Indemnification

To the extent permitted by Applicable Law, users agree to defend, indemnify, and hold harmless Cardiosense, its affiliates, officers, directors, employees, contractors, licensors, successors, and assigns from and against any claims, damages, judgments, penalties, losses, liabilities, costs, and reasonable attorneys’ fees arising out of or relating to:

violation of these Terms;
misuse of the Services;
violation of Applicable Law;
infringement of third-party rights by User Content;
negligent or wrongful acts of the user;
unauthorized access resulting from the user’s failure to protect account credentials.

Cardiosense shall promptly notify the indemnifying party of any indemnified claim and shall reasonably cooperate in its defense.

51. Force Majeure

Cardiosense shall not be liable for delays or failures in performance caused by events beyond its reasonable control, including:

acts of God;
natural disasters;
epidemics or pandemics;
war;
terrorism;
civil unrest;
labor disputes;
governmental actions;
internet outages;
failures of cloud service providers;
telecommunications failures;
utility interruptions;
cybersecurity attacks;
shortages of materials or components.

Cardiosense shall use commercially reasonable efforts to resume performance as soon as reasonably practicable.

52. Suspension of Services

Cardiosense may suspend access to all or part of the Services without prior notice where reasonably necessary to:

protect patient safety;
investigate suspected fraud;
respond to cybersecurity threats;
prevent unauthorized access;
comply with Applicable Law;
perform emergency maintenance;
protect the integrity or availability of the Services.

Where practicable, Cardiosense will provide notice of the suspension and restore access promptly after the underlying issue has been resolved.

53. Termination

These Terms remain effective until terminated.

Users may discontinue use of the Services at any time.

Cardiosense may terminate or suspend access immediately if:

these Terms are materially breached;
continued access presents a cybersecurity risk;
required fees remain unpaid;
use of the Services violates Applicable Law;
use presents an unreasonable risk to patient safety;
Cardiosense is required to do so by governmental authority.

Termination does not affect accrued rights or obligations existing before termination.

The following Sections survive termination to the extent applicable:

Intellectual Property
Confidentiality
Feedback
Warranty Disclaimer
Limitation of Liability
Indemnification
Governing Law
Dispute Resolution
Miscellaneous

54. Regulatory Compliance

Users remain responsible for complying with all Applicable Laws governing their use of the Services.

Nothing contained in these Terms transfers regulatory responsibilities assigned by law to healthcare providers, healthcare organizations, distributors, importers, authorized representatives, or other regulated entities.

Users remain responsible for complying with:

medical device regulations;
privacy laws;
cybersecurity requirements;
record retention obligations;
reimbursement requirements;
professional licensing obligations;
applicable clinical standards.

Where users become aware of information reasonably suggesting that a Cardiosense product may have malfunctioned or contributed to a serious injury or death, users should promptly notify Cardiosense in accordance with applicable reporting procedures and Applicable Law.

55. Governing Law

These Terms shall be governed by and construed in accordance with the laws of the State of Illinois, without regard to its conflict of laws principles.

The United Nations Convention on Contracts for the International Sale of Goods shall not apply.

56. Dispute Resolution

The parties agree to make good-faith efforts to resolve disputes through informal negotiations before initiating litigation or arbitration.

If a dispute cannot be resolved informally, the parties agree that any legal proceeding shall be brought exclusively in the state or federal courts located in Illinois, unless a separate written agreement provides otherwise.

Each party irrevocably submits to the jurisdiction of such courts.

If Cardiosense elects to require arbitration for certain categories of users, this Section may be replaced with a binding arbitration provision consistent with Applicable Law.

57. Electronic Communications

Users consent to receive notices, disclosures, agreements, invoices, security notifications, software update notices, and other communications electronically.

Electronic communications satisfy any legal requirement that such communications be provided in writing, except where Applicable Law requires otherwise.

58. Modifications to These Terms

Cardiosense may modify these Terms from time to time.

Material modifications will become effective upon the effective date identified in the revised Terms or as otherwise communicated.

Continued use of the Services after the effective date constitutes acceptance of the revised Terms.

If a user does not agree to the revised Terms, the user must discontinue use of the Services.

59. Miscellaneous

These Terms constitute the entire agreement between Cardiosense and the user regarding the Services unless superseded by a separate written agreement.

If any provision is determined to be invalid or unenforceable, the remaining provisions shall remain in full force and effect.

Failure by Cardiosense to enforce any provision shall not constitute a waiver of that provision or any other provision.

Users may not assign these Terms without Cardiosense’s prior written consent.

Cardiosense may assign these Terms in connection with a merger, acquisition, corporate reorganization, sale of assets, or operation of law.

Headings are included solely for convenience and do not affect interpretation.

References to statutes include amendments and successor provisions unless the context requires otherwise.

60. Contact Information

Questions regarding these Terms & Conditions should be directed to:

Cardiosense, Inc.
Compliance Department
400 N Aberdeen St Suite 1050
Chicago, IL 60642
United States

Email: [email protected]
Website: www.cardiosense.com

Acknowledgment

BY ACCESSING OR USING THE SERVICES, YOU ACKNOWLEDGE THAT YOU HAVE READ THESE TERMS & CONDITIONS, UNDERSTAND THEM, AND AGREE TO BE LEGALLY BOUND BY THEM.

If you are accepting these Terms on behalf of an organization, you represent and warrant that you have authority to bind that organization to these Terms & Conditions.

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