MSLCU46002 Trolley Color Doppler Ultrasound System — 19-Inch HD Monitor, 10.4-Inch Touchscreen, 3D/4D Imaging, Four Probe Ports | Two-Probe Configuration

FDA and U.S. Regulatory Disclaimer Prescription Medical Device. This diagnostic ultrasound system is intended for use by qualified physicians, sonographers, technicians, and other licensed or appropriately trained healthcare professionals. Federal law may restrict this device to sale by or on the order of a licensed healthcare practitioner in accordance with applicable prescription-device labeling requirements. Diagnostic ultrasound systems and their transducers are regulated medical devices in the United States. Before this model or any associated probe is offered for clinical use in the United States, the purchaser and distributor must confirm that the exact system, software configuration, transducer models, indications for use, and accessories are covered by an applicable FDA marketing authorization, including a valid 510(k) clearance when required. FDA clearance of one manufacturer, platform, or similar device does not establish clearance of the MSLCU46002 or any probe listed on this product page. FDA’s ultrasound guidance provides specific recommendations for the marketing clearance of diagnostic ultrasound systems and transducers. No representation of FDA approval is made. Unless Truway Health provides the applicable FDA clearance number and authorized indications in the final quotation or regulatory documentation package, the product must not be represented as “FDA approved,” “FDA cleared,” or authorized for any particular clinical application. Product photographs, technical descriptions, vendor literature, and website publication do not constitute FDA authorization. The system is intended to assist trained professionals with diagnostic imaging and fluid-flow assessment within the indications authorized for the supplied configuration. Ultrasound findings must be interpreted together with the patient’s clinical history, physical examination, laboratory findings, and other medically appropriate diagnostic information. Ultrasound imaging can assist healthcare professionals in evaluating and diagnosing medical conditions but does not independently establish every diagnosis. Safety and Use Limitations Professional use only. The system is not intended for unsupervised consumer, home, recreational, entertainment, or non-medical use. Authorized indications only. Use is limited to the anatomical regions, patient populations, imaging modes, probes, and clinical applications stated in the manufacturer’s authorized labeling and instructions for use. ALARA operation. Operators must apply the “As Low As Reasonably Achievable” principle by using the lowest acoustic output and shortest examination time necessary to obtain diagnostically useful information. Diagnostic ultrasound does not use ionizing radiation, but ultrasound energy may produce biological effects under certain settings and exposure conditions. Acoustic-output monitoring. The operator must monitor the displayed Mechanical Index, Thermal Index, output power, dwell time, focal position, and other available safety indicators, particularly during obstetric, fetal, neonatal, ophthalmic, transcranial, and sensitive-tissue examinations. FDA-cleared diagnostic ultrasound systems commonly provide thermal and mechanical acoustic-output indices to support informed operation. No keepsake fetal imaging. The system should not be used solely to create souvenir fetal images, videos, or recordings without a medically indicated examination and appropriate professional oversight. FDA discourages casual or non-medical exposure to diagnostic ultrasound. Probe compatibility. Only manufacturer-approved transducers, cables, adapters, biopsy guides, software modules, and accessories may be connected. Unapproved components may impair image quality, electrical safety, acoustic-output control, measurement accuracy, or regulatory compliance. Endocavitary probe controls. Transvaginal and other endocavitary probes require appropriate single-use barriers, cleaning, leak testing, and high-level disinfection between patients as specified in the probe manufacturer’s instructions and the healthcare facility’s infection-control procedures. Measurements are operator dependent. Measurements, calculations, Doppler estimates, elastography values, fetal measurements, cardiac calculations, and automated analysis outputs must be reviewed by a qualified professional. Poor probe contact, incorrect presets, patient motion, anatomy, body habitus, artifacts, inappropriate angle correction, and operator technique may affect results. Not a substitute for clinical judgment. Images and calculated values must not be used as the sole basis for diagnosis, treatment, surgery, medication selection, or exclusion of disease. Configuration-dependent features. 3D/4D imaging, continuous-wave Doppler, tissue Doppler, elastography, anatomical M-mode, DICOM, measurement packages, reporting software, printers, storage devices, and specialty applications may require optional hardware, probes, licenses, or factory activation. Installation requirements. Installation must be completed in accordance with the manufacturer’s electrical, grounding, ventilation, electromagnetic-compatibility, environmental, network-security, and operating-space requirements. Image disclaimer. Website images are illustrative and may show optional probes, software screens, accessories, furniture, clinicians, or room environments not included in the standard package. Final appearance and configuration may differ. Truway Health Limited Commercial Warranty Warranty Term Truway Health provides a five-year limited commercial warranty for the MSLCU46002 ultrasound system when the warranty term is expressly included in the customer’s final quotation, invoice, or purchase agreement. Coverage Schedule Year 1 — System Parts and Remote Technical Support Covered electronic and mechanical system components Main monitor and integrated touchscreen Control-panel electronics and user controls System computer, internal power supply, and probe-connector assembly Remote troubleshooting and technical-support coordination Replacement of covered defective parts, subject to diagnosis and authorization Years 2–5 — Limited System Parts Coverage Covered non-consumable system components Replacement parts supplied at Truway Health’s discretion Remote diagnostic assistance Labor, travel, freight, customs, installation, and on-site service excluded unless separately contracted Probe Warranty Supplied ultrasound probes are covered against verified defects in materials and workmanship for twelve months from delivery, unless a different probe warranty is stated in the final quotation. Probe coverage does not include: Cracks, cuts, abrasions, or separation of the probe cable Damage from dropping, impact, crushing, bending, or improper storage Lens or acoustic-array damage Connector-pin damage Liquid intrusion Damage caused by incompatible cleaners or disinfectants Damage caused by excessive heat, immersion beyond permitted limits, autoclaving, or unauthorized sterilization Damage to endocavitary probes resulting from improper handling, leak testing, cleaning, or disinfection Warranty Conditions Warranty coverage applies only when: The equipment was purchased directly from Truway Health or an authorized channel. The invoice and serial number can be verified. Installation, operation, maintenance, cleaning, and storage comply with the manufacturer’s instructions. The system is operated by trained personnel. Required preventive maintenance and electrical-safety inspections are documented. The original serial numbers, labels, seals, and configuration records remain intact. The purchaser promptly reports the alleged defect and provides requested diagnostic information. Warranty Exclusions The limited warranty does not cover: Normal cosmetic wear Consumables, gel, paper, batteries, probe covers, storage media, or cleaning materials Damage during customer-arranged transportation Accidents, misuse, negligence, abuse, unauthorized modification, or improper installation Power surges, incorrect voltage, inadequate grounding, liquid spills, fire, flood, environmental contamination, or other external events Malware, network intrusion, unsupported software, third-party applications, or unauthorized system updates Failure caused by accessories, probes, printers, adapters, or peripherals not approved for the system Image-quality complaints resulting from patient factors, operator technique, improper presets, or unsupported applications Calibration, preventive maintenance, software upgrades, cybersecurity updates, or regulatory recertification unless expressly included Loss of data, archived examinations, reports, patient information, or network connectivity Downtime, lost revenue, substitute-equipment costs, or consequential commercial losses Warranty Remedy Truway Health’s obligation is limited, at its option, to: Remote troubleshooting; Repair of the covered component; Replacement with a new, refurbished, or functionally equivalent component; or Replacement of the covered system when repair is commercially impracticable. Replacement equipment or parts may be new or professionally refurbished and assume the remaining term of the original warranty. Warranty service does not restart or extend the original warranty period unless required by applicable law. Service Authorization No equipment or probe may be returned without a written Return Material Authorization. The customer must follow the packaging, decontamination, data-removal, and shipping instructions supplied with the authorization. Patient-contact equipment must be cleaned and disinfected before return, and Truway Health may reject equipment that presents an infection-control or transportation hazard. Limitation of Liability To the maximum extent permitted by law, Truway Health’s total liability arising from the product will not exceed the amount paid for the specific covered product giving rise to the claim. Truway Health is not liable for indirect, incidental, special, punitive, or consequential damages, including lost profits, loss of use, loss of data, delayed procedures, or the cost of substitute equipment. Final Warranty Qualification This website warranty is a general commercial summary. The final quotation, purchase agreement, manufacturer documentation, serial-number record, and applicable service contract control in the event of a conflict. Regulatory authorization, installation, training, calibration, preventive maintenance, and on-site service are included only when expressly identified as line items in the executed order.

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