Purchasing a Radiofrequency Ablation (RFA) Tumor Treatment System

HT performed tumor ablation using radiofrequency ablation (RFA).

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HT

A. General Requirements: 100% New Product, Manufacturing Year from 2026 onwards, Power Supply: 220V/50Hz or suitable for use in Vietnam. B. Expected Configuration Requirements: 1. General Requirements: * Utilizes Radiofrequency (RF) ablation technology for treating lesions/tumors as indicated by medical professionals. * Capable of being used in various procedures, including percutaneous interventions, endoscopy, or surgery, as designed and specified by the manufacturer. * Includes monitoring functions for parameters during ablation, such as power, current, impedance, temperature, and duration, or equivalent parameters, to ensure treatment control. * Provides alerts or detects neutral electrode connection status and abnormal conditions during operation. * Capable of storing, viewing, or exporting information, logs, or equivalent data from the procedure. * Meets applicable medical device safety and electromagnetic compatibility standards or equivalent standards. * Manufacturer has a suitable quality management system for medical devices, such as ISO 13485 or equivalent. * Device has appropriate legal documentation according to current regulations for medical equipment in Vietnam. 2. Main Machine: * Includes an integrated RF generator and control system. * Features a display screen for easy parameter setting and monitoring during treatment. * Capable of using 1 to 3 electrodes, as designed by the system. * Offers both automatic or manual ablation modes. * Allows control or adjustment of one or more parameters during ablation, such as power, temperature, duration, impedance, or equivalent parameters. * Includes a hemostasis function when withdrawing the electrode, if designed by the manufacturer. * RF Power: Suitable for treatment purposes and electrode design of the system. * Frequency: Suitable for device design and intended use. * Includes a function to monitor impedance during ablation. * Allows setting of RF transmission time and automatic stopping when the set time is complete or when termination conditions are met. * Provides alerts if abnormal conditions are detected, such as impedance, temperature, electrode connection, or neutral electrode status. 3. Cooling Pump: * Includes a cooling pump suitable for the ablation electrode with a cooling system. * Capable of providing stable cooling during procedures. * Flow rate appropriate for the requirements of the electrode and system. 4. RF Ablation Electrodes: * The system is capable of using electrodes suitable for treatment needs, including at least: * Fixed heat source ablation electrode; * Electrodes with different heat source head sizes; * Multi-electrode array electrodes, if supported by the system; * Bipolar electrodes, if supported by the system; * Electrodes with internal cooling systems, compatible with the cooling pump. * Electrodes must have appropriate size, working length, and heat source head length for the intended treatment of lesions or sizes. 5. Neutral Electrodes: * Includes neutral electrodes suitable for the system and electrode. * Provides a function to recognize/monitor neutral electrode connection status or equivalent safety functions. * Initial supply quantity: Suitable for device configuration. 6. Foot Pedal: * Includes a foot pedal to control the device. * Minimum Start/Stop function or equivalent. 7. Accessories: * Provides all standard accessories to enable normal operation of the device, including but not limited to: Cooling pump; Electrodes according to the manufacturer's standard configuration; Neutral electrodes; Coolant tubing; Foot pedal; Other standard accessories as designed by the manufacturer; Dedicated cart or equivalent, suitable for placing the machine and accessories; User manual in Vietnamese and English. The supplier may offer products with different configurations and specifications than those listed above if they can demonstrate that the products meet equivalent or better functionality, performance, safety, and application range.

TTYT KV Vĩnh Tường (likely an abbreviation for a specific entity)