EyeLux Portable and In-Office— Terms and Conditions of Sale

Applies to EyeLux Portable and In-Office devices purchased directly from EyeLux Integrations, LLC

1. Seller and scope

These Terms and Conditions of Sale (Terms) govern purchases of EyeLux Portable and In-Office devices directly from EyeLux Integrations, LLC (EyeLux). They apply to orders placed through EyeLux’s online store or other purchase channels that expressly incorporate these Terms. EyeLux Multisensory Training (MST) Tables and their associated software, services, and training are governed by their separate written purchase and license agreements, not these Portable Terms.

2. Qualified purchasers; no patient resale

EyeLux devices are offered for sale only to licensed healthcare professionals and healthcare practices operating under the responsibility of appropriately licensed professionals. The purchaser represents that it meets that requirement and that its representative is authorized to purchase. Providers may use devices in their practices and may rent or loan them to patients under appropriate professional oversight. Resale of EyeLux devices to patients is prohibited.

3. Product purpose and provider judgment

The EyeLux devices are currently marketed for wellness use and has not received FDA clearance or approval. No particular individual outcome is represented or guaranteed. Purchasing providers remain responsible for their own clinical judgment, professional licensing, evaluation of patient suitability, and compliance with applicable laws, standards of care, and any instructions or labeling supplied with the device. EyeLux does not establish or supervise individualized patient protocols.

4. Written operating and safety instructions

EyeLux supplies written operating and safety instructions with each EyeLux device. The purchasing provider must review those instructions, follow applicable device operating and maintenance guidance, and ensure that personnel and home-use patients receive appropriate instructions. The provider must not make unauthorized alterations or permit use of a device known or reasonably suspected to be unsafe.

5. Conditions for rental or loan to patients

Before releasing an EyeLux device for patient home use, the purchasing provider must determine patient suitability, establish an individualized use protocol, provide the patient with appropriate EyeLux operating and safety instructions, ensure the patient understands the applicable precautions, and supply a telephone number for the supervising practice. The provider shall obtain any patient consent required by applicable law or professional standards and maintain appropriate documentation of patient instruction and consent in the patient’s records. The provider remains responsible for supervising home use in accordance with the other provisions of these Terms.

6. Monitoring and response to symptoms

The provider is responsible for appropriate monitoring of patients using rented or loaned devices, for adjusting or discontinuing the individual protocol when indicated, and for maintaining patient records according to applicable professional requirements. Providers must instruct patients to stop using the device and promptly contact the supervising provider if unexpected, uncomfortable, or worsening symptoms occur, and to obtain emergency medical assistance when appropriate.

7. Inspection, cleaning, and reassignment

Before assigning a returned rental or loan device to another patient, the provider must inspect it for damage, verify proper function, and clean it in accordance with EyeLux’s written instructions. The provider must maintain an inspection and cleaning record identifying the device, date, and responsible staff member, using the practice’s own recordkeeping process. A device with damage, malfunction, or suspected safety problems must be removed from service pending evaluation and clearance for further use.

8. Product safety incidents and notification

The provider must promptly notify EyeLux of suspected malfunctions, equipment-related injuries, or other device safety concerns. The provider must immediately discontinue use of a device suspected to be unsafe and instruct any patient in possession of the device to discontinue use. The provider should preserve the device and relevant information when safe to do so and reasonably cooperate in incident evaluation. Patient information should be provided only when disclosure is legally permitted.

9. Provider professional liability insurance

The purchasing provider or practice must maintain professional liability insurance appropriate to its activities, including patient assessment, instruction, supervision, and home-use monitoring. Evidence of such coverage shall be provided to EyeLux upon reasonable request. This requirement does not alter EyeLux’s responsibilities as manufacturer.

10. Indemnification for provider conduct

To the extent permitted by law, the purchasing provider agrees to indemnify and hold harmless EyeLux from third-party claims, damages, and reasonable expenses to the extent caused by the provider’s professional negligence, improper device use, failure to follow EyeLux’s operating or safety instructions, or material breach of these Terms. This obligation does not extend to losses to the extent attributable to EyeLux’s own negligence, a manufacturing defect, or any responsibility EyeLux may not lawfully transfer.

11. Ordering, pricing, and delivery

The applicable product price, taxes, shipping charges, and delivery information will be identified at checkout or on an accepted invoice. Orders are subject to availability and verification. EyeLux may contact the purchaser to correct a material ordering or listing error before accepting the order. Any special financing, customization, or payment schedule must be confirmed in writing.

12. Returns and refunds

Qualifying direct purchases of EyeLux devices are subject to the separately published EyeLux Return and Refund Policy. The policy does not modify a separately signed MST Table purchase agreement. Rights and remedies that cannot lawfully be excluded remain unaffected.

13. EyeLux Portable and In-Office— limited manufacturer warranty

For new EyeLux devices sold by EyeLux, EyeLux provides a 90-day limited manufacturer warranty beginning on the date the original purchasing provider receives the device. The warranty covers defects in materials and workmanship under normal, instructed use. EyeLux will repair or replace a device with a confirmed covered defect without charge for covered parts and labor, at EyeLux’s reasonable discretion. EyeLux pays both inbound and return shipping for confirmed covered defects. The warranty does not cover accidental damage, misuse, unauthorized modifications, or normal wear and tear. The purchaser should contact EyeLux before shipping a device for service and provide the order information, serial number, and description of the issue. Nothing in this paragraph reduces any non-waivable statutory warranty or other legal remedy or changes warranties already provided on earlier purchases.

14. Software and connected services

Hardware purchase does not automatically include perpetual access to separately licensed software or connected services. If a software or service subscription is purchased, its charges, renewal terms, cancellation method, and other material conditions will be disclosed in the terms for that service before enrollment. This sale agreement does not itself enroll a customer in a recurring paid service.

15. Warranty of results; responsibility for clinical decisions

EyeLux does not guarantee an individual patient outcome or that a particular protocol will achieve a specific result. The provider remains responsible for its patient assessments, individualized protocols, treatment decisions, instructions, supervision, and documentation. Nothing in these Terms excuses EyeLux from liability for its own unlawful conduct or defective products.

16. Contractual limitations

To the extent permitted by law, neither party shall be liable to the other for speculative or indirect business losses arising solely from a breach of this sales agreement, such as lost anticipated profits. This limitation does not restrict claims for bodily injury or physical property damage attributable to a defective product, or any liability that applicable law prohibits the parties from limiting.

17. Governing terms and changes

Ohio law governs this agreement to the extent permitted by applicable law. Any amendment to these Terms applies prospectively and does not retroactively change an accepted order. If a separate signed agreement governs a specific transaction, that written agreement controls the matters it expressly covers.

18. Acceptance and records

An authorized purchasing representative must affirmatively accept the applicable EyeLux Terms and Conditions of Sale, Return and Refund Policy, and product warranty at online checkout. EyeLux may retain evidence of acceptance associated with the order, including the accepted policy version and date, in accordance with its record retention practices and applicable law.

19. Questions, safety reports, and service

EyeLux Integrations, LLC  |  eyeluxintegrations@gmail.com |  https://eyeluxintegrations.com/contact-us