Objectives

The primary objective of this tender is to procure adult manual resuscitators that meet specified technical and quality standards for use at GJGM Regional Hospital under the KwaZulu-Natal Department of Health. The process aims to ensure the supply of reliable, compliant, and effective medical equipment that adheres to national standards and departmental requirements.

Scope

The scope encompasses the supply, delivery, installation, testing, calibration, and commissioning of adult manual resuscitators. It includes providing necessary documentation such as manuals and certificates, offering training and technical support, and ensuring compliance with specifications, standards, and legal requirements. The procurement covers optional accessories, spare parts, and warranty services for the equipment's lifecycle.

Technical Requirements

• The resuscitator must be autoclavable up to 170°C.
• Meet ISO, ASTM, CSA, and JIS standards.
• Constructed from polysulfone, silicone rubber, and polyvinyl chloride materials.
• Dimensions: 15/22mm ISO patient connector, 24mm silicone neck, 26mm inlet, 25mm oxygen reservoir, 6mm oxygen inlet.
• Flow resistance less than 2cm H2O at 5 L/min.
• Oxygen delivery concentration of 99% at 15 L/min with reservoir attached.
• Pressure relief of 60 ± 10cm H2O at 60 L/min flow.
• Attachment point for PEEP valve (if applicable).
• Maximum/stroke volume: 1350-1600ml.
• Breath cycle rate: 45 B.P.M. (600ml).
• Reservoir volume: 2500-2600ml.
• Warranty: Minimum 24 months with guaranteed uptime of at least 99%.
• Guarantee/ warranty conditions must be met, including breakdown coverage and downtime extension.
• Compliance with electrical safety standards IEC 60601-1 and 60601-1-2, CE certification, and hospital-grade mains plug.
• Provision of manuals, software, optional accessories, and spare parts for at least 10 years.
• Equipment must be new, unused, and compliant with all specified standards and certifications.

Skills Requirements

• Manufacturers or suppliers must demonstrate technical and clinical evaluation by a government or recognized institution within RSA.
• Provide full training to Health Technology Services' in-house technicians on calibration, maintenance, repair, and troubleshooting down to PCB level, with proof of manufacturer training.
• Establish and maintain a well-equipped service and repair facility within KwaZulu-Natal, with qualified technicians trained by the original equipment manufacturer.
• Supply comprehensive manuals (operation, maintenance, repair) in English, properly bound or digital, including fault-finding guides, circuit diagrams, PCB layouts, and calibration procedures.
• Ensure availability of spare parts, upgrades, and technical support for at least 10 years, with a commitment to supply spares at no extra cost during the warranty period and beyond.
• Provide demonstration units and participate in acceptance testing with departmental representatives.
• Maintain compliance with electrical, safety, and hazardous substance regulations, including Radiation Control licensing if applicable.
• Offer optional accessories, software updates, and upgrade policies, with clear timelines and cost implications.