FDA-STYLE LIMITED WARRANTY, USE LIMITATIONS AND LIABILITY NOTICE PRODUCT LINE: BIOBASE BKX-FY Series Dental Negative Pressure Suction Systems APPLICABLE MODELS: BKX-FY02, BKX-FY03, BKX-FY05, BKX-FY07 and BKX-FY10 DISTRIBUTOR: Truway Health, Inc. PRODUCT PURPOSE: The BIOBASE BKX-FY Series is designed to provide negative-pressure suction for the removal of saliva, blood, fluids and treatment debris during dental procedures. Available models support approximately 1 to 15 dental chairs, depending on the selected system and facility configuration. The manufacturer’s product sheet identifies rated suction capacities ranging from 780 L/min to 3,800 L/min. 1. LIMITED PRODUCT WARRANTY Unless a different warranty term is expressly stated in the applicable Truway Health quotation, purchase agreement or invoice, this equipment is supplied under the written warranty terms accompanying the individual sale. During the applicable warranty period, Truway Health, Inc. or the manufacturer, as appropriate, will evaluate properly submitted claims involving an alleged defect in materials or workmanship arising under normal installation, operation and maintenance conditions. The exclusive warranty remedy may consist of one or more of the following, as determined after technical evaluation: A. Remote technical support; B. Repair of the affected component; C. Replacement of a defective component; D. Replacement of the affected equipment; E. Commercial credit or refund when repair or replacement is not reasonably available. Repair, replacement or credit does not automatically extend or restart the original warranty period unless expressly confirmed in writing. 2. CONDITIONS OF WARRANTY COVERAGE Warranty service is conditioned upon the purchaser providing: A. The Truway Health order or invoice number; B. The product model and serial number; C. The installed voltage, frequency and phase configuration; D. The installation date and installer’s information; E. A description of the reported failure; F. Photographs, video, diagnostic information or service records when requested; G. Evidence that required maintenance and cleaning procedures were performed; H. Reasonable access to inspect, test or return the affected equipment or component. No equipment may be returned without prior written authorization and applicable return instructions. 3. WARRANTY EXCLUSIONS The limited warranty does not cover damage, deterioration or failure resulting from: A. Incorrect installation, plumbing, drainage, ventilation or electrical connection; B. Connection to an incorrect voltage, frequency, phase, circuit or grounding system; C. Voltage surges, brownouts, unstable electrical supply or failure to use required protective equipment; D. Operation beyond the supported number of dental chairs or rated suction capacity; E. Improper operation, misuse, abuse, neglect or unauthorized clinical application; F. Failure to follow manufacturer instructions, cleaning procedures or preventive-maintenance requirements; G. Blocked suction lines, accumulated debris, fluid ingress or improper waste handling; H. Biological, chemical, mineral, corrosive or environmental contamination; I. Unauthorized repair, alteration, disassembly or replacement with nonapproved components; J. Accident, impact, fire, flood, water damage, pests, extreme temperature or other external causes; K. Damage occurring during transportation, unloading, storage or site movement after delivery; L. Normal wear of filters, hoses, seals, collection vessels, connectors, tubing, fuses and other service items; M. Cosmetic damage that does not affect safe operation; N. Installation or use inconsistent with applicable building, electrical, plumbing, occupational-safety or healthcare-facility requirements. Consumables and routine maintenance items are not covered unless expressly identified as warrantable components in writing. 4. ELECTRICAL AND INSTALLATION LIMITATIONS The purchaser must confirm the required electrical configuration before ordering. BKX-FY02 and BKX-FY03 configurations may be offered in 220V/50Hz, 220V/60Hz or 110V/60Hz versions, subject to factory confirmation. The manufacturer’s technical sheet identifies different standard and optional electrical configurations for the higher-capacity BKX-FY05, BKX-FY07 and BKX-FY10 models. Therefore, the voltage, frequency, phase, motor configuration, plug type and site power requirements must be confirmed in writing before manufacture, shipment or installation. :contentReference[oaicite:1]{index=1} Installation must be completed by qualified personnel familiar with dental vacuum systems, electrical equipment, fluid-management systems and applicable local requirements. Truway Health, Inc. is not responsible for site preparation, electrical upgrades, plumbing modifications, drainage work, wall penetrations, cabinetry modifications, ventilation changes or permitting unless those services are separately included in the written order. 5. CLINICAL AND OPERATIONAL LIMITATIONS This equipment is an accessory system intended to support dental suction and fluid-removal operations. It is not intended to: A. Independently diagnose a disease or medical condition; B. Replace professional clinical judgment; C. Replace required infection-prevention procedures; D. Replace high-volume evacuation, isolation or aerosol-control measures required by facility protocol; E. Sterilize suctioned fluids, tubing or treatment areas; F. Process hazardous, radioactive or incompatible chemical materials; G. Operate without appropriate separators, filters, traps, waste containers or drainage controls; H. Be used outside the manufacturer’s stated performance limits. The user facility remains responsible for establishing procedures for infection control, line cleaning, waste segregation, amalgam management where applicable, personal protective equipment and occupational exposure prevention. 6. REGULATORY NOTICE Product descriptions, technical specifications, quotations, invoices, website listings and promotional materials do not independently constitute evidence of registration, listing, clearance, approval, certification or authorization by the United States Food and Drug Administration or any other regulatory authority. No statement in this warranty should be interpreted as representing that a particular model is FDA cleared, FDA approved, FDA registered or authorized for a specific use unless Truway Health provides separate written documentation supporting that representation. Before purchase, importation, resale or clinical use, the purchaser is responsible for confirming all applicable: A. Device classification requirements; B. Establishment registration and device-listing requirements; C. Premarket authorization requirements; D. Importation and customs requirements; E. Labeling and language requirements; F. Electrical-safety and electromagnetic-compatibility requirements; G. State and local facility requirements; H. Installation, sanitation and environmental-disposal requirements. Regulatory documentation must be evaluated for the exact model, configuration, manufacturing site and intended market. 7. PERFORMANCE DISCLAIMER Published suction capacity, vacuum range, noise level, electrical consumption, chair capacity, dimensions and weight are manufacturer-stated specifications. Actual performance may vary according to: A. Pipe diameter and total pipe length; B. Number of bends, fittings and vertical rises; C. Simultaneous chair usage; D. Filter and separator condition; E. Installation quality; F. Site elevation and ambient conditions; G. Electrical-supply stability; H. Maintenance condition; I. Type and volume of material being evacuated. Selection of a model based solely on the maximum stated chair count is not recommended without a site-specific capacity assessment. 8. SHIPPING AND FREIGHT LIMITATIONS Equipment must be inspected promptly upon delivery. Visible freight damage, shortage, puncture, crushing, water exposure or pallet damage must be documented on the carrier’s delivery receipt before acceptance whenever possible. Concealed damage must be reported within the time allowed by the carrier and the applicable sales agreement. The purchaser must retain: A. The original carton; B. Pallet and protective materials; C. Shipping labels; D. Delivery receipt; E. Photographs of the exterior and interior packaging; F. Photographs of the equipment and damaged area. Failure to preserve packaging or document freight damage may limit the ability to recover from the carrier. Freight damage is not considered a manufacturing defect. 9. LIMITATION OF LIABILITY To the maximum extent permitted by applicable law, Truway Health, Inc., the manufacturer and their respective officers, employees, representatives, contractors and suppliers will not be liable for indirect, incidental, special, punitive, exemplary or consequential damages arising from the purchase, transportation, installation, operation, malfunction or inability to use the equipment. Excluded damages may include, without limitation: A. Lost revenue or profit; B. Lost clinical time; C. Appointment cancellation; D. Facility shutdown; E. Business interruption; F. Replacement-equipment rental; G. Loss of data or records; H. Third-party claims; I. Labor, construction or site-restoration costs; J. Regulatory penalties resulting from the purchaser’s noncompliance; K. Injury or property damage caused by unauthorized installation, alteration or misuse. Except where prohibited by law, the total cumulative liability associated with the product will not exceed the amount actually paid to Truway Health for the specific unit giving rise to the claim. Nothing in this section excludes liability that cannot legally be excluded or limited under applicable law. 10. DISCLAIMER OF ADDITIONAL WARRANTIES Except for the express written warranty provided with the sale, and to the extent permitted by law, the equipment is supplied without additional express or implied warranties. Truway Health, Inc. disclaims implied warranties of merchantability, fitness for a particular purpose, uninterrupted operation and noninfringement except where such disclaimers are prohibited by law. No oral statement, sales representation, website description or technical discussion modifies the warranty unless incorporated into a written agreement signed or expressly issued by Truway Health, Inc. 11. PURCHASER RESPONSIBILITIES The purchaser is responsible for: A. Selecting the appropriate model and capacity; B. Confirming electrical and installation requirements; C. Obtaining required permits and inspections; D. Using qualified installation and service personnel; E. Maintaining service and cleaning records; F. Training authorized operators; G. Preventing operation by unqualified personnel; H. Following manufacturer instructions and safety warnings; I. Maintaining appropriate infection-control and waste-management procedures; J. Removing the equipment from service when unsafe operation is suspected; K. Reporting serious incidents or product problems through applicable facility and regulatory channels. 12. WARRANTY CLAIM PROCEDURE All warranty requests should include: Purchaser Name: Facility Name: Truway Health Order Number: Model: Serial Number: Voltage and Frequency: Installation Date: Installer: Date Problem Was First Observed: Detailed Description of Problem: Error Indicator or Alarm: Maintenance History: Photographs or Video Attached: Requested Resolution: Submission of a claim does not constitute acceptance of warranty coverage. Coverage is determined after review of the equipment history, installation conditions, technical evidence and applicable written warranty terms. 13. FINAL NOTICE Specifications, accessories, electrical configurations, packaging, component availability and warranty procedures may change without notice. The final commercial quotation, invoice, factory confirmation, approved submittal and manufacturer documentation control over conflicting website or promotional content. Purchasers should retain all sales, installation, service and regulatory documents for the useful life of the equipment.

No reviews yet Write a Review