BIOBASE Blood Bag Tube Sealer Series — Medical PVC Blood Collection Tubing Heat Sealing Systems | Manual, Automatic & Multi-Voltage Models

Warranty, Limitations and Liability Limited Equipment Warranty Truway Health, Inc. warrants that the Blood Bag Tube Sealer will be free from material defects in workmanship and supplied components for 3 years beginning on the documented delivery date, unless a different warranty period is stated in the applicable quotation, invoice, purchase agreement, or manufacturer documentation. During the warranty period, Truway Health may, at its discretion and subject to manufacturer authorization, repair the equipment, replace a defective component, provide an equivalent replacement unit, or issue an appropriate commercial credit. Warranty service may require photographs, operating logs, serial-number verification, diagnostic information, return authorization, and shipment of the affected equipment to an approved service location. This limited warranty applies only to the original purchaser and is not transferable unless expressly authorized in writing. Intended Use and Professional-Use Limitation This equipment is intended for the thermal sealing of compatible medical PVC tubing associated with blood collection bags in appropriately controlled blood-bank, transfusion-service, laboratory, research, or blood-processing environments. Model-specific tubing dimensions, voltage requirements, sealing times, and operating parameters must be verified before use. The available models have different supported tube diameters, wall-thickness limits, sealing cycles, electrical configurations, and triggering mechanisms. The equipment must be installed, operated, inspected, cleaned, and maintained by trained personnel in accordance with the current manufacturer instructions, facility procedures, applicable electrical requirements, blood-handling precautions, and quality-control protocols. This product is a tubing-sealing device and is not represented as a sterilizer, blood-processing analyzer, diagnostic instrument, or substitute for clinical judgment. Operator Responsibilities Before each use, the operator must confirm: Compatibility of the tubing material, outside diameter, and wall thickness; Correct voltage, frequency, power connection, and equipment configuration; Cleanliness and condition of the sealing head, splash guard, housing, and working area; Appropriate sealing-time or power settings; Proper alignment of the tubing within the sealing area; and Visual and procedural verification of each completed seal. The purchaser and operating facility are solely responsible for validating the sealing process for their tubing, blood-bag system, workflow, environmental conditions, and intended application. A completed seal must be inspected according to the facility’s approved procedure before the tubing or associated blood product is released, stored, transported, processed, or used. Warranty Exclusions The warranty does not cover damage, malfunction, premature wear, or performance failure resulting from: Incorrect voltage, unstable power, unauthorized adapters, or improper electrical installation; Use with tubing outside the specified material, diameter, or wall-thickness range; Improper sealing settings, repeated overheating, obstruction, contamination, or operator misuse; Blood, fluid, chemical, or cleaning-agent intrusion into internal components; Failure to clean, inspect, maintain, or service the equipment as instructed; Unauthorized repair, disassembly, calibration, alteration, or replacement of components; Use of unapproved accessories, consumables, cables, or replacement parts; Accidents, drops, impact, improper storage, corrosion, fire, flooding, infestation, or other external causes; Cosmetic damage that does not materially affect operation; Normal wear of sealing heads, heating elements, protective films, switches, indicators, fuses, and other serviceable components; Freight damage not documented with the carrier at delivery; or Use outside the equipment’s labeled or documented intended purpose. Consumables and normal-wear components are excluded unless expressly identified as covered in writing. Regulatory Notice Product descriptions, specifications, registration information, manufacturer records, and commercial availability must not be interpreted as evidence that the product has been cleared, approved, authorized, certified, or endorsed by the U.S. Food and Drug Administration. FDA establishment registration or device listing does not, by itself, constitute FDA approval. The purchaser is responsible for determining whether the selected model may lawfully be imported, marketed, installed, or used in the purchaser’s jurisdiction and whether any establishment registration, device listing, premarket submission, authorization, license, permit, validation, or institutional approval is required. Medical-device labeling should provide appropriate directions, precautions, warnings, and limitations associated with the device’s intended use. No FDA clearance or approval claim should be added to this product page unless Truway Health possesses current, model-specific documentation supporting that exact regulatory status. Limitation of Liability To the maximum extent permitted by applicable law, Truway Health, Inc., the manufacturer, and their respective suppliers, representatives, and service providers will not be liable for indirect, incidental, special, punitive, exemplary, or consequential damages, including loss of blood products, specimens, revenue, contracts, production time, clinical capacity, data, or anticipated savings, arising from installation, operation, failure, misuse, delayed service, or inability to use the equipment. Truway Health does not assume responsibility for improperly sealed tubing, compromised blood products, cross-contamination, operator injury, facility downtime, regulatory noncompliance, or patient-related consequences resulting from failure to follow the manufacturer instructions, inadequate process validation, incompatible tubing, improper maintenance, unauthorized modification, or failure to inspect and verify each seal. Where liability cannot legally be excluded, the aggregate liability associated with the product will not exceed the amount actually paid for the affected unit, except where a different remedy is required by applicable law. No Additional Warranties Except for the limited written warranty stated above, the equipment is supplied without additional express or implied warranties, including implied warranties of merchantability, fitness for a particular clinical or commercial purpose, uninterrupted operation, or compatibility with every blood-bag or tubing system, to the extent such exclusions are permitted by law. Specifications, appearance, packaging, accessories, firmware, and component sourcing may be revised by the manufacturer without notice, provided that the delivered equipment substantially conforms to the applicable confirmed quotation or purchase agreement.

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