Tender For Causa Cautry ( High Electrosurgical Units With Vessel Sealing); 01 Specification for Cusa Cautery (High End Electrosurgical Units with Vessel Sealing) 1. General Requirements & Technology Description: An integrated, high-end Electro Surgical Unit (ESU) with advanced vessel sealing capabilities, designed for open, laparoscopic, and endoscopic surgeries. It shall be upgradable with Argon Plasma System, smoke evacuation, irrigation pump, and Hydrojet System, Control Micro-Processor/Micro-Controller based Technology: technology for precise and intelligent control. Certifications: US-FDA/European CE (Notified Body) approved product, marked in accordance with the Medical Devices Directive 93/42/EEC), Class 1 Equipment, Electromagnetic Compatibility Certificate, and 150 Certificate. Must also comply with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 safety standards. Display: At least a 7-inch touch screen TFT Focus View display with LCD backlight adjustment for excellent visibility in the operating room. Output Dosage & Regulation: Automatic output dosage for all regulative technologies, with precise power output adjusted to the individual indication. The unit shall feature display graph facility to show delivered power, and separate modes with automatic power regulation, voltage regulation, and arc regulation to prevent tissue damage and charring. 2. Safety & Monitoring Patient Plate Contact Monitoring: Continuous Patient Plate Contact Monitoring system to prevent patient burns. The unit shall automatically cut off power delivery in case of no contact or insufficient contact, accompanied by an audible and visual alarm. Tissue Impedance Monitoring: Real-time tissue impedance monitoring for optimal surgical effect. HF Leakage Monitoring: System should have HF leakage monitoring & controlling system. Self-Test: System shall perform a self-test upon power-up. 3. Operational Modes & Outputs Program Storage: Ability to store a minimum of 198 or more customized user programs, with facility to configure for custom setups based on relevant discipline, indication, or procedure. Operating Frequency. In a range of 350-500 KHz. Cutting Modes (At least 8): Auto Cut, High Cut, Dry Cut, Precise Cut, Bipolar Cut, Bipolar Precise Cut, Pure Cut, Low Cut, Erbe Cut, Blend Cut. Coagulation Modes (At least 8): Soft Coagulation, Swift Coagulation, Twin Coagulation, Classic Coagulation, Precise Coagulation, Forced Coagulation, Spray Coagulation, Bipolar Soft Coagulation, Bipolar Forced Coagulation, Fulguante, Desiccate. Bipolar Modes: Cut, Force, Micro, Auto Start/Stop function, and Ligate (L1-15). Power Output: Maximum Monopolar Cut Output: 400 Watt ➤ Maximum Monopolar Coagulation Output: 200 Watt Maximum Bipolar Cut Output: 120 Watt ➤ Maximum Bipolar Coagulation Output: 80 Watt Output Sockets: Dual Monopolar outputs which can be operated simultaneously by either one or two surgeons, one Bipolar Output Socket, and one Neutral socket for all types of Reusable & Disposable Neutral Plates. The system should have separate generators for Monopolar and Bipolar.. 4. Vessel Sealing The system shall include a dedicated vessel sealing system for both open and laparoscopic surgery, with built-in cutting and coagulation capabilities for laparoscopic instruments. Accessories All accessories supplied with the ESU Unit must be from the same Original Equipment Manufacturer (OEM) Footswitch with facility for swapping between programs: 2 Nos (including at least one Magnetic wireless Pedal foot switch). Reusable Capacitive Return Electrode: 1 No. This should be a signal-side coupling current quality monitoring electrode, usable for patients above 11 kg, latex-free, and cause no adhesive-related irritation to patient skin. (Pad Size: 980 mm (long) x 450 mm (wide), Pad Thickness: 9 mm (thick), Pad Weight: 4.7 kgs). OEM Patient plate with equipotential ring: 50 Nos. Reusable Vessel sealer for Lap Surgery: 1 Nos. Dedicated Vessel Sealing instruments for open procedure: 1 Nos. Monopolar Handswitch Pencil (Reusable): 10 Nos. Disposable Vessel Sealer Probe: 2 Nos. Mains cable with power plug for standard indian sockets: 1 No. Bipolar forceps with cable: 1 No. Set of electrodes: 1 set. 6. Service & Documentation. Service Support: The OEM Principal company must have mandatory regional & head offices for providing after-sales service with a dedicated team of trained service engineers/representatives. Warranty & Maintenance: Comprehensive warranty for 3 years and 2 years Comprehensive Maintenance Service (CMS) after the warranty period. are not Documentation: Product literature in original for the unit and all accessories (photocopies/computer-generated copies acceptable), statement of compliance with tender specifications with product literature, and certificate of clear links manufacturer/provider regarding authorization of the service facility. to a
