FDA/Regulatory Disclaimer and Purchaser Acknowledgment FDA requirements cannot be waived through a product-page disclaimer. The following language is intended as a regulatory disclosure and purchaser acknowledgment, not as a waiver of applicable law. The MSL MSLTU002 Trolley Color Doppler Ultrasound System and each compatible transducer are medical devices whose lawful importation, distribution, installation, and clinical use depend on the exact manufacturer, model, software version, probe configuration, intended use, labeling, and destination-country authorization. Diagnostic ultrasound systems and transducers are subject to FDA medical-device requirements, and FDA publishes specific 510(k) guidance for these products. No representation of FDA approval or clearance is made unless the final quotation, invoice, or regulatory documentation expressly identifies the applicable FDA marketing authorization and the exact covered system and transducer models. FDA registration, establishment listing, a device listing, or assignment of a product code does not by itself mean that a device is FDA approved or cleared. Applicable authorization should be verified through FDA’s device-clearance and approval resources. Where the supplied configuration is designated as a prescription device, federal law restricts sale to or on the order of an appropriately licensed healthcare practitioner. The purchaser is responsible for confirming professional-use restrictions, facility licensing, import requirements, electrical certifications, cybersecurity policies, and all other laws applicable to the destination and intended use. This product is not intended for recreational, entertainment, keepsake, or unsupervised consumer imaging. FDA discourages ultrasound exposure performed solely for non-medical fetal keepsake images or videos. Clinical and Operational Limitations The MSLTU002 is intended to assist qualified healthcare professionals in acquiring and evaluating diagnostic ultrasound images. It does not independently diagnose, exclude, prevent, cure, or treat any disease or medical condition. Images, measurements, calculations, Doppler values, automated outputs, and reports must be interpreted by an appropriately trained and licensed professional together with the patient’s history, examination, laboratory findings, and other relevant clinical information. Only manufacturer-approved probes, cables, adapters, software modules, peripherals, and accessories may be connected. Use of an incompatible or unauthorized component may affect image quality, acoustic output, measurement accuracy, electrical safety, electromagnetic compatibility, system performance, warranty coverage, or regulatory compliance. Available imaging modes and applications depend on the purchased configuration. Optional 3D imaging may require a compatible volume probe, software license, factory activation, additional memory, or other hardware. DICOM, printer connectivity, measurement packages, reporting functions, storage capacity, probe-frequency ranges, and specialty presets must be confirmed in the final configuration documentation. Operators must use ultrasound energy prudently and follow the ALARA principle—As Low As Reasonably Achievable—using the lowest output and shortest examination time necessary to obtain clinically adequate information. Endocavitary and other patient-contact probes must be cleaned, disinfected, inspected, leak-tested, covered, stored, and reprocessed according to the manufacturer’s instructions, facility infection-control policies, and applicable standards. Probes must not be autoclaved, immersed, or exposed to chemicals unless expressly permitted by the probe manufacturer. Performance may be affected by operator technique, incorrect presets, probe selection, probe angle, acoustic-window limitations, patient motion, body habitus, anatomy, artifacts, electrical interference, network conditions, unsupported software, or environmental conditions. The purchaser is responsible for operator training, preventive maintenance, electrical-safety testing, cybersecurity controls, data backup, and compliance with privacy requirements. Product photographs and illustrations may show optional probes, software displays, carts, peripherals, furniture, or accessories that are not included with every configuration. Final specifications and appearance may vary according to manufacturing revision and purchased options. Truway Health Limited Commercial Warranty The MSLTU002 system is covered only for the warranty period expressly stated in the final Truway Health quotation, invoice, purchase agreement, or service contract. No website statement expands the written warranty included with the executed order. When a three-year limited system warranty is expressly included, coverage is structured as follows: Year 1: Covered parts, remote technical support, and reasonable remote diagnostic assistance for verified defects in materials or workmanship. Years 2–3: Covered system parts and remote support only. On-site labor, technician travel, freight, duties, customs charges, deinstallation, reinstallation, calibration, loaner equipment, and facility expenses are excluded unless separately purchased. Ultrasound transducers are covered for 12 months from delivery against verified defects in materials and workmanship unless the final quotation states a different period. Probe coverage excludes lens damage, cable cuts, strain damage, connector-pin damage, liquid intrusion, impact, drops, crushing, misuse, improper reprocessing, unauthorized chemicals, excessive heat, unsupported sterilization, and normal wear. Warranty service requires proof of purchase, product and probe serial numbers, installation records where applicable, photographs or diagnostic logs, and compliance with the manufacturer’s operating and maintenance instructions. Truway Health may require remote troubleshooting before authorizing repair or return. The exclusive warranty remedy, at Truway Health’s option, is remote troubleshooting, repair, replacement of a covered component, supply of a new or professionally refurbished equivalent part, or replacement of the covered system when repair is commercially impracticable. Replacement parts or systems assume only the remaining balance of the original warranty period. No product may be returned without prior written return authorization. Patient-contact equipment must be properly cleaned, disinfected, packaged, and accompanied by any required decontamination declaration before shipment. Warranty Exclusions The warranty does not cover consumables, batteries, printer supplies, gel, probe covers, storage media, cosmetic wear, preventive maintenance, calibration, software upgrades, cybersecurity updates, lost data, third-party software, unauthorized repairs, altered serial numbers, misuse, negligence, improper installation, incorrect voltage, inadequate grounding, power surges, fire, flood, liquid spills, transportation damage, environmental contamination, or use outside the manufacturer’s specifications. The warranty also excludes failures caused by incompatible probes, accessories, printers, networks, adapters, operating systems, or third-party peripherals. Disclaimer of Other Warranties Except for the express written warranty included with the executed order, and to the maximum extent permitted by applicable law, Truway Health disclaims all other warranties, whether express, implied, statutory, or otherwise, including implied warranties of merchantability, fitness for a particular purpose, non-infringement, uninterrupted operation, diagnostic accuracy, or suitability for a purchaser’s specific clinical, regulatory, reimbursement, or commercial requirements. No employee, sales representative, reseller, website statement, image, advertisement, or oral communication may modify the warranty unless the modification is included in a written agreement signed by an authorized Truway Health representative. Limitation of Liability To the maximum extent permitted by applicable law, Truway Health’s total aggregate liability arising from the MSLTU002 system, any probe, accessory, service, or transaction shall not exceed the amount actually paid to Truway Health for the specific product or service giving rise to the claim. Truway Health will not be liable for indirect, incidental, special, exemplary, punitive, or consequential damages, including loss of revenue, loss of profits, loss of data, loss of clinical use, delayed procedures, patient rescheduling, business interruption, substitute-equipment expense, regulatory penalties, reimbursement denial, or reputational harm. The purchaser remains responsible for independent clinical judgment, diagnosis, treatment decisions, operator credentialing, patient consent, infection control, equipment maintenance, data security, regulatory compliance, and confirmation that the ordered configuration is lawful and appropriate for its intended use. Nothing in this limitation excludes or restricts liability that cannot lawfully be excluded under the governing law. The executed quotation, invoice, purchase agreement, manufacturer documentation, and service contract control if they conflict with the product-page summary.

No reviews yet Write a Review