Objectives

The primary objective of this tender is to procure a high power electrosurgical unit that is robust, user-friendly, employs the latest technology, and ensures reliability and safety during surgical procedures. The equipment must facilitate various surgical outputs while incorporating proven safety features to prevent patient burns and injuries.

Scope

The scope encompasses the supply, delivery, installation, commissioning, and demonstration of a High Power Electrosurgical Unit suitable for general surgery. The unit must support monopolar and bipolar modes, perform multiple functions such as cutting and coagulation, and include necessary accessories and consumables. The tender also covers training, servicing, maintenance, and provision of spare parts for a specified period.

Technical Requirements

• The unit must generate variable output power, displayed digitally, with a frequency range of approximately 200 kHz to 3.5 MHz.
• Support monopolar and bipolar modes with specified functions:
  • Monopolar: Pure cut (0-350W), coagulation (0-120W), blend, spray coagulation.
  • Bipolar: Variable power from 0-70W in cut and coagulation modes.
• The unit must have safety features including alarms for activation, patient contact issues, and neutral electrode disconnection, with automatic power reduction or shutdown as needed.
• The equipment must comply with IEC 60601-1, IEC 60601-1-2 standards, and carry CE certification.
• The device should be splash-proof, with detachable footswitch and accessories, and include a trolley with brakes and storage drawer.
• Supply of a starter pack of consumables and accessories such as footswitch, patient electrodes, and cables.
• The unit must operate off a 220V ±10%, 50Hz mains supply with a minimum 3-meter hospital-grade mains cable.
• Guarantee a minimum of 24 months warranty, with provisions for maintenance and repairs, including spare parts availability for at least 10 years.
• Include optional accessories and a schedule of additional items for immediate operational readiness.

Skills Requirements

• The supplier must have a well-established service and repair facility within KwaZulu-Natal, capable of servicing, repairing, and calibrating the equipment.
• Qualified technicians must be manufacturer-trained, with proof of training, and be available within 24 hours for maintenance or repairs.
• The bidder must provide comprehensive training to the Department’s technical staff on calibration, maintenance, and repair down to PCB level, with certification of competency.
• The supplier must supply detailed manuals, software, and troubleshooting tools at no additional cost.
• Ability to demonstrate the equipment's performance and compliance through evaluation and clinical trials, if required.
• Proven experience in supplying and supporting high-frequency surgical equipment, with references and evaluation reports where applicable.