## FDA, Regulatory, Warranty, Limitations and Liability Notice ### 1. FDA and Regulatory Disclaimer The Coreray CR Series Video Laryngoscope and Airway Visualization System is intended for purchase and use only by appropriately trained, qualified, and authorized healthcare professionals or medical institutions. FDA establishment registration, device listing, owner/operator identification, or assignment of a registration number does not, by itself, constitute FDA approval, clearance, certification, endorsement, or authorization of a manufacturer, distributor, facility, or medical device. Any representation regarding FDA clearance, approval, exemption, authorization, product code, device classification, establishment registration, or device listing applies only when supported by current, verifiable documentation for the exact model, configuration, software version, blade, holder, stylet, accessory, and intended use being supplied. Truway Health, Inc. does not independently expand, modify, or supplement the manufacturer’s cleared or authorized indications for use. Purchasers must review the current manufacturer labeling, Instructions for Use, contraindications, warnings, precautions, cleaning instructions, and regulatory documentation before purchasing or placing the device into clinical service. Availability does not constitute a representation that every configuration may be lawfully imported, sold, distributed, or used in every jurisdiction. The purchaser is responsible for determining local licensing, registration, importation, prescription-device, facility, and professional-use requirements. ### 2. Prescription and Professional-Use Restriction This product is intended for professional clinical use. It is not intended for unsupervised consumer or home use. The device must be selected, operated, cleaned, disinfected, sterilized, stored, inspected, maintained, and serviced only by personnel trained in airway management and in the manufacturer’s current operating and reprocessing instructions. The product listing, photographs, specifications, demonstrations, and sales materials are informational and do not replace: * Professional medical judgment; * Formal airway-management training; * Facility policies and emergency protocols; * The manufacturer’s Instructions for Use; * Patient-specific risk assessment; or * Applicable laws, regulations, and professional standards. ### 3. No Medical Advice or Clinical Guarantee Truway Health, Inc. does not provide medical advice through this product listing. No guarantee is made that use of the device will result in successful visualization, intubation, airway placement, diagnosis, treatment, or patient outcome. Clinical results may vary according to patient anatomy, airway condition, operator training, technique, blade selection, equipment condition, environmental conditions, and other factors outside the distributor’s control. The device must not be used as a substitute for clinical judgment, appropriate monitoring, backup airway equipment, or an established difficult-airway and emergency-response plan. ### 4. Limited Product Warranty Unless a different written warranty period is stated on the final quotation, sales order, invoice, or manufacturer warranty certificate, the equipment is supplied with a **limited twelve-month warranty** beginning on the documented delivery date. During the applicable warranty period, the warrantor may, at its discretion: * Diagnose the reported defect; * Repair the affected equipment; * Replace a defective covered component; * Supply an equivalent replacement component; or * Provide another remedy expressly approved in writing. Warranty service is subject to: * Verification of the serial number and purchase record; * Timely written notice of the reported defect; * Completion of requested troubleshooting procedures; * Return authorization before shipment; * Proper decontamination and packaging of returned equipment; and * Inspection confirming a covered manufacturing defect. Repair or replacement does not automatically extend the original warranty period. A repaired or replacement component will be covered for the remaining original warranty period or any additional period expressly stated in writing. ### 5. Items Not Covered by Warranty The limited warranty does not cover: * Disposable blades, sterile products, or single-use components; * Normal wear, cosmetic damage, scratches, discoloration, or battery aging; * Routine maintenance, calibration, inspection, cleaning, disinfection, or sterilization; * Damage caused by misuse, abuse, negligence, dropping, impact, liquid ingress, fire, theft, or improper storage; * Use outside the manufacturer’s stated environmental or electrical specifications; * Improper assembly, installation, charging, operation, reprocessing, or maintenance; * Use of incompatible blades, holders, stylets, cables, chargers, batteries, accessories, software, or replacement parts; * Unauthorized repair, modification, disassembly, alteration, or software changes; * Damage caused by third-party accessories, network systems, electrical supply, cybersecurity incidents, malware, or unauthorized connectivity; * Failure to follow the Instructions for Use or facility infection-control procedures; * Damage arising during transportation after delivery unless covered by a separately documented freight claim; * Products with removed, altered, obscured, or illegible serial numbers or labels; * Products used after expiration, package damage, loss of sterility, or suspected contamination; or * Any use outside the device’s labeled intended use. ### 6. Disposable and Sterile Product Limitations Disposable blades and products identified as single-use must not be cleaned, reprocessed, resterilized, or reused unless expressly permitted by applicable manufacturer labeling and law. Opened, used, contaminated, expired, damaged, temperature-compromised, or sterile products with broken packaging are nonreturnable except when required by applicable law or when a verified manufacturing defect existed before use. Sterility is not guaranteed after the labeled expiration date or after the sterile barrier has been opened, punctured, wet, crushed, altered, or otherwise compromised. ### 7. Reusable Component and Reprocessing Limitation Reusable blades, visual holders, video stylets, and other reusable components must be reprocessed strictly according to the manufacturer’s current validated instructions. The purchaser and user facility are responsible for: * Selecting compatible cleaning and disinfection agents; * Observing temperature, exposure-time, and sterilization limits; * Inspecting components before and after each use; * Maintaining reprocessing and maintenance records; * Removing damaged equipment from service; and * Preventing cross-contamination and patient exposure. Truway Health, Inc. is not responsible for damage, contamination, infection, loss of performance, or injury caused by improper reprocessing, incompatible chemicals, excessive sterilization cycles, failure to inspect the device, or deviation from validated procedures. ### 8. Product Specifications and Compatibility Specifications, photographs, screen displays, packaging, accessories, software, firmware, included components, color, labeling, and country-specific configurations may be changed by the manufacturer without prior notice. The purchaser must confirm before ordering: * Exact manufacturer model and MPN; * Screen size; * Blade or holder configuration; * Adult, pediatric, neonatal, or difficult-airway compatibility; * Electrical and charging requirements; * Video-output and connectivity functions; * Language and labeling requirements; * Included accessories; * Sterility and package quantity; * Regulatory status; and * Compatibility with existing equipment. No accessory, blade, holder, cable, video stylet, Wi-Fi module, or third-party component should be presumed compatible unless compatibility is confirmed in the manufacturer documentation or in writing. ### 9. Software, Data and Connectivity Limitation Where Wi-Fi, NFC, HDMI, USB, image storage, video recording, or data-transfer functions are available, the purchaser is responsible for evaluating cybersecurity, privacy, network, access-control, data-retention, and system-integration requirements. No representation is made that the device is compatible with every hospital network, electronic health-record system, monitor, storage device, cybersecurity platform, or third-party software environment. Truway Health, Inc. is not responsible for data loss, unauthorized access, network interruption, software incompatibility, cybersecurity incidents, corruption, transmission failure, or use of patient information contrary to applicable privacy laws or facility policy. ### 10. Limitation of Liability To the maximum extent permitted by applicable law, Truway Health, Inc., its affiliates, officers, employees, representatives, suppliers, and logistics providers will not be liable for indirect, incidental, special, exemplary, punitive, or consequential damages, including: * Lost profits or revenue; * Loss of use; * Business interruption; * Lost or corrupted data; * Replacement-equipment costs; * Clinical delays; * Loss of opportunity; * Patient claims arising from unauthorized or improper use; or * Damages caused by third-party products or services. To the maximum extent permitted by law, aggregate liability arising from the sale or supply of a product will not exceed the amount actually paid to Truway Health, Inc. for the specific product giving rise to the claim. Nothing in this notice excludes or limits liability that cannot lawfully be excluded or limited. ### 11. Purchaser Responsibilities By purchasing, receiving, installing, or using the product, the purchaser accepts responsibility for: * Confirming that the selected model is suitable for the intended application; * Ensuring that users are properly licensed, credentialed, and trained; * Maintaining appropriate backup airway and emergency equipment; * Following all manufacturer warnings and Instructions for Use; * Complying with applicable FDA, state, local, institutional, privacy, infection-control, and professional requirements; * Inspecting the shipment promptly for shortage, damage, or discrepancy; * Maintaining serial-number, service, cleaning, and adverse-event records; and * Discontinuing use immediately when damage, malfunction, contamination, or unsafe performance is suspected. ### 12. Adverse Events, Complaints and Safety Reporting Suspected malfunctions, serious injuries, deaths, device failures, labeling problems, sterility concerns, or other safety complaints should be documented and reported promptly to Truway Health, Inc. and the manufacturer. Healthcare facilities, manufacturers, and importers must independently determine and satisfy any applicable Medical Device Reporting or other regulatory-reporting obligations. Reporting a complaint to the distributor does not replace any mandatory report that must be submitted directly to FDA or another regulatory authority. The affected device, packaging, labels, accessories, serial-number information, photographs, cleaning records, and relevant supporting documentation should be preserved when safe and legally appropriate. ### 13. Returns and Service Authorization No equipment may be returned without prior written return-material authorization. Returned medical equipment must be: * Properly decontaminated; * Accompanied by a signed decontamination statement; * Packaged to prevent additional damage; * Shipped according to the provided instructions; and * Identified with the applicable order, model, serial number, and complaint information. Truway Health, Inc. may refuse contaminated, improperly packaged, unauthorized, incomplete, or hazardous returns. ### 14. Controlling Documentation If this product-listing notice conflicts with the manufacturer’s current labeling, Instructions for Use, written warranty, applicable law, approved purchase order, or signed sales agreement, the following order of precedence will apply unless otherwise agreed in writing: 1. Applicable law and regulatory requirements; 2. Signed contract or approved purchase order; 3. Manufacturer labeling and Instructions for Use; 4. Manufacturer warranty documentation; 5. Final Truway Health quotation or invoice; and 6. General website product-listing language. **Important:** Verify the exact FDA marketing status, U.S. agent information, device listing, establishment registration, 510(k) number if applicable, and confirmed manufacturer warranty period for each Coreray model before publishing this notice as a model-specific regulatory statement.

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