Objectives

The primary objective of this tender is to procure a Spirometer that meets the technical and quality standards required by Ngwelezane Hospital to facilitate lung function testing, including spirometry, lung volume measurements, and diffusion capacity assessments. The procurement aims to ensure the hospital acquires reliable, certified, and fully supported equipment to enhance respiratory diagnostics and patient care.

Scope

The scope encompasses the supply, delivery, installation, calibration, testing, and commissioning of three (3) portable hand-held spirometers. The equipment must conform to specified technical standards, including compliance with national and international safety and quality standards, and must be supported by appropriate training, servicing, and spare parts availability within KwaZulu-Natal. The procurement is a once-off contract with a validity period of 90 days from the date of advertisement.

Technical Requirements

• The spirometer must be a full lung function system capable of measuring:
  • Slow and forced spirometry
  • Functional residual capacity (FRC) via Nitrogen Wash Out without CO2 absorption canister
  • Residual volume (RV) and total lung capacity (TLC)
  • Single breath diffusion testing
  • Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP)
  • Body Plethysmography (airway resistance and volume measurements)
• The system must be mounted on a mobile, compact trolley with integrated isolating transformer.
• Demand valve unit for direct breathing from pre-mix gas containers with adjustable support arm and pneumotach for flow/volume measurement.
• The equipment must perform accurate FRC Nitrogen Wash Out tests without CO2 absorber.
• Sensors, especially gas sensors, must ensure correct operation without re-calibration for at least 5 hours.
• The system must include internal software for calibration, with internal gas flow measurement accuracy, resolution, and resistance specifications clearly stated.
• The unit must have integrated automatic BTPS (Body Temperature, Pressure, Saturation) correction built-in.
• The equipment must be CE Certified, comply with IEC 60601-1 safety standards, and operate off a 220V, 50Hz mains supply with hospital-grade mains plug.
• All equipment must be new, CE certified, and supported by comprehensive manuals, calibration software, and troubleshooting tools.
• The system must be capable of demonstrating compliance with technical and clinical evaluation standards, with provisions for future software upgrades and updates at no additional cost.

Skills Requirements

• The successful 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, with proof of original equipment manufacturer (OEM) training submitted with the bid.
• Technicians should be available within 24 hours to attend to malfunctions, with detailed contact information provided.
• The bidder must supply a list of technicians, including names, contact numbers, and employment status (permanent or subcontracted).
• Provision of full training to Health Technology Services staff on calibration, maintenance, repair, and troubleshooting of the equipment is mandatory, with certificates of competency issued upon completion.
• Spare parts, consumables, and software updates must be available for at least 10 years from the manufacturer, with a commitment to supply at no extra cost during the warranty and support period.
• The bidder must demonstrate capacity to provide after-hours technical support and loan units if equipment is taken for repairs.