Objectives

The primary objective of this tender is to procure a Spirometer that meets detailed technical specifications for full lung function testing, including spirometry, lung volume measurements, diffusion capacity, and related functionalities. The equipment should support accurate, reliable, and clinically validated lung function assessments to enhance diagnostic and monitoring capabilities within Ngwelezane Hospital.

Scope

The scope encompasses the supply, delivery, installation, calibration, testing, and commissioning of the specified spirometer system. It includes providing comprehensive training, maintenance, and support services for the equipment over the warranty and lifecycle period. The procurement is for a full lung function system compliant with specified standards, suitable for use in a hospital environment, and supporting various lung function tests as detailed in the specifications.

Technical Requirements

• The equipment must be a full lung function system capable of:
  • Slow and forced spirometry, including lung volumes (FRC, RV, TLC), single breath diffusion, MIP and MEP testing, and body plethysmography.
  • Quick analysis of single breath diffusion capacity within 1 minute.
  • Mounted on a mobile, compact trolley with integrated isolating transformer.
  • Support for direct breathing from pre-mix gas containers with adjustable support arms and pneumotach exchangeable flow sensors.
  • Ability to perform FRC Nitrogen Wash Out tests without CO2 absorption canisters.
  • Gas sensors with a minimum stability of 5 hours without recalibration.
  • Integrated automatic BTPS correction and calibration features.
  • Includes calibration syringes, regulators, and software for accurate gas calibration.
  • Compliance with ATS/ERS clinical performance standards for flow and resistance measurements.
  • Use of long-life durable sensors, especially for gas analysis.
  • Support for bi-directional differential pressure pneumotach with specified accuracy and resolution.
  • Use of NDIR infrared sensors for CO analysis with specified range and response time.
• The system must be CE certified and compliant with IEC 60601-1 and 60601-1-2 electrical safety standards.
• The equipment should include comprehensive manuals, software, and calibration tools, with provisions for future software updates and upgradeability.
• The system must be supplied with all necessary accessories, disposables, and spare parts for at least 10 years.
• Guarantee and warranty of at least 24 months, with specified service and maintenance support, including on-site repairs and training.

Skills Requirements

• The bidder must have a well-established service and repair facility within KwaZulu-Natal, capable of servicing, calibrating, and repairing the equipment.
• Technicians must be manufacturer-trained and certified to handle the specific equipment offered, with proof of training provided.
• Availability of qualified in-house technicians or authorized subcontractors within 24 hours for maintenance and repairs.
• The bidder must provide comprehensive training to hospital staff and in-house technicians on calibration, operation, maintenance, and repair of the equipment, including PCB-level troubleshooting.
• Provision of technical support, spare parts, and software updates throughout the equipment's lifecycle.
• Demonstration of compliance with relevant standards and evaluation by government or recognized clinical institutions is advantageous.