Objectives

The primary objective of this tender is to procure a Diathermy Machine through supply and delivery to the Harry Gwala District Office, Department of Health in KwaZulu-Natal. The process aims to ensure the acquisition of a compliant, quality medical device that meets specified standards, with appropriate training, servicing, and warranty provisions.

Scope

The scope encompasses the supply, delivery, installation, testing, calibration, and demonstration of the Diathermy Machine at the designated hospital site. It includes providing manuals, optional accessories, training, maintenance, and support services as specified in the detailed technical and contractual specifications. The procurement is for a once-off purchase with associated after-sales support, warranty, and optional upgrades.

Technical Requirements

• The machine must be a high-frequency electrosurgical unit (350 W) suitable for general surgery, employing solid state technology.
• Must include monopolar and bipolar modes with functions such as cut, coagulation, blend, and spray coagulation.
• Power output ranges:
  • Low: 0 – 20 W (increments of 0.1 W up to 10 W)
  • High: 0 – 35 W (increments of 1 W)
  • Bipolar: 0 – 35 W (increments of 1 W)
• Features:
  • Self-test on startup
  • Digital display of output power
  • Audible and visual alarms for safety issues
  • Automatic power reduction on neutral electrode disconnection
  • Patient contact monitoring
  • Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 standards
  • CE or equivalent certification
• Accessories:
  • Power up/down autoclavable handpiece with 3m cord
  • Wall mount kit
  • Disposable and reusable electrodes and tips
  • Procedural video and manuals
• Guarantee period of at least 24 months with specified uptime (preferably ≥99%)
• Provision for future software and hardware upgrades at no additional cost
• Complete documentation including operation manuals, service manuals, and software keys
• Compliance with electrical safety, EMC, and hazardous substances regulations

Skills Requirements

• Proven technical expertise in electrosurgical equipment, including installation, calibration, and maintenance.
• Authorized training of in-house technicians for calibration, servicing, and repair down to PCB level, with certification of competency.
• Availability of a well-established service and repair facility within KwaZulu-Natal, with qualified technicians trained by the manufacturer.
• Capability to provide ongoing technical support, software updates, and spare parts supply for the equipment’s lifecycle.
• Experience in demonstrating and training end-users on the operation and safety features of the device.
• Compliance with all relevant safety, quality, and regulatory standards, including CE certification and radiation control licensing where applicable.