Objectives

The primary objective of this tender is to procure a Hand-Held Spirometer that meets specified technical standards, ensuring accurate lung function testing, compliance with safety and quality standards, and the ability to support clinical and diagnostic needs at Ngwelezane Hospital.

Scope

The scope encompasses the supply, delivery, installation, calibration, testing, and commissioning of three units of portable spirometers. The procurement includes training, provision of manuals, spare parts, and ongoing technical support to ensure optimal operation throughout the equipment's lifecycle at Ngwelezane Hospital, KwaZulu-Natal.

Technical Requirements

• Device must be portable, hand-held, and constructed from durable plastic, with standard size and white color.
• Must conform to SABS approved quality standards and meet the detailed specifications provided in the procurement documents.
• Equipment must operate on 220V, 50Hz AC supply with a hospital-grade mains plug (minimum 3m length) and IEC 60601-1 safety certification.
• System must include calibration, maintenance, troubleshooting software, and support for software updates and recalls.
• Equipment must be CE certified and comply with international electrical safety standards.
• Spare parts, accessories, and software must be supplied for at least 10 years post-delivery.
• Guarantee period of at least 24 months with guaranteed uptime of at least 99%, including all costs for repairs, maintenance, and QA testing during the warranty period.
• Equipment must be capable of demonstrating clinical evaluation and must be supported by descriptive literature, brochures, and technical data sheets.
• Training must be provided to technical staff for calibration, maintenance, and repair down to PCB level, with certificates of competency issued upon completion.

Skills Requirements

• Bidder must have a well-established service and repair facility within KwaZulu-Natal capable of servicing, repairing, and calibrating the equipment.
• Technicians must be manufacturer-trained, certified, and available within 24 hours for maintenance and repairs.
• Bidder must provide full training to Health Technology Services staff, including calibration, troubleshooting, and repair procedures, with comprehensive manuals and software.
• Bidder must supply ongoing technical support, spare parts, and software updates for a minimum of 10 years.
• Demonstration of the equipment at the hospital site or designated location may be required for evaluation purposes.