Objectives

The primary objective of this tender is to supply and deliver an Automated External Defibrillator (AED) machine that meets specified technical and safety standards, ensuring reliable life-saving functionality in medical emergencies. The procurement aims to enhance emergency response capabilities at Ndwedwe CHC by providing a certified, high-quality defibrillator with comprehensive training, maintenance, and support provisions.

Scope

The scope encompasses the supply, delivery, installation, commissioning, and demonstration of one AED defibrillator machine at Ndwedwe CHC. It includes providing related accessories, optional extras, spare parts, training, and ongoing support as specified in the detailed technical and contractual specifications. The contract covers compliance with national standards, safety regulations, and departmental requirements for medical devices within KwaZulu-Natal.

Technical Requirements

• The AED must be a biphasic automated external defibrillator suitable for ground and air ambulance use, with adult and paediatric capabilities.
• The device must conform to IEC 601-2-4 safety standards and IEC 60601-1 electrical safety standards.
• Operation must comply with 2006 American Heart Association guidelines, including impedance compensation before shock delivery.
• The AED should have preconfigured adult and paediatric energy settings, with clear display and voice prompts.
• The unit must include ECG monitoring with standard leads and display ECG waveform with automatic gain control and sweep speed of 25 mm/sec.
• The device must be lightweight, robust, and include a high-resolution LCD display showing shock count, prompts, heart rate, ECG, and battery status.
• It must be supplied with at least one rechargeable, interchangeable battery with specified charge/discharge cycles and quick recharge time.
• The AED should include disposable pads with a minimum shelf life of two years, and optional accessories such as a waterproof carry case.
• Automated self-checks must be performed daily, weekly, and monthly, testing pads, battery, circuitry, and energy charges.
• The device must be supplied with comprehensive manuals, calibration software, and training support, including manufacturer-certified technicians.
• Guarantee period of at least 12 months, with minimum 99% uptime, and provisions for maintenance, repairs, and software updates.

Skills Requirements

• Proven experience in supplying and servicing medical electrical equipment, specifically AEDs and defibrillators.
• Technical expertise in device installation, calibration, and maintenance, with manufacturer-certified technicians available within KwaZulu-Natal.
• Capability to provide comprehensive training to hospital staff and technical personnel on device operation, troubleshooting, and routine maintenance.
• Ability to demonstrate compliance with national and international safety standards, including IEC and IEC 60601 series.
• Experience in providing ongoing technical support, software updates, and spare parts supply for medical devices over the device lifecycle.
• Knowledge of regulatory requirements, including Radiation Control licensing and Hazardous Substance Act compliance, where applicable.