Objectives

The primary objective is to procure a single portable vein visualization system equipped with a mobile stand for clinical use at Ngwelezana Hospital. The device aims to assist healthcare professionals in accurately locating subcutaneous veins, thereby improving vascular access procedures across diverse patient demographics and reducing puncture-related complications.

Scope

• Item: Vein Viewer Version 2 with Mobile Stand (Quantity: 01)
• Contract Type: Once-off supply
• Delivery Period: Maximum 15 working days (3 weeks) from contract award
• Inclusions: Delivery, installation, commissioning, acceptance testing, initial training, starter accessories, comprehensive documentation, and a minimum 24-month warranty
• Validity: Quotation valid for 90 days
• Evaluation Stages: Administrative compliance, technical specification adherence, price/preference scoring, and mandatory physical sample submission

Technical Requirements

• Imaging & Operation: Non-contact, safe infrared/light-based imaging without lasers or radiation. Must function reliably in both lit and dark clinical environments.
• Performance Metrics: Projection distance of 29–31 cm; light intensity between 300–1000 lux. Powered by rechargeable lithium-ion polymer batteries (3.0–4.2 V DC) delivering over 4 hours of continuous operation.
• Design & Build: Wheeled mobile trolley featuring an articulating arm and flexible wrist joint. Constructed from metal and plastic with a white finish. Weight specified at approximately 136.078 kg.
• Clinical Compatibility: Validated for use on neonates, paediatrics, adults, obese/edematous patients, dark-skinned individuals, and those presenting with anemia, hypotension, or significant blood loss.
• Regulatory Compliance: Must hold CE certification, comply with IEC 60601-1/60601-1-2 medical electrical standards, SANS wiring codes, and Occupational Health and Safety legislation. Valid SAHPRA distribution license is mandatory.
• Documentation & Support: Provision of two sets each of user and service manuals (physical/digital), calibration/maintenance software, fault-finding guides, circuit diagrams, and PCB layouts. Spare parts must remain commercially available for ten years.
• Warranty & Maintenance: Minimum 24-month guarantee commencing post-commissioning. Covers all labour, spares, travel, and QA testing. Downtime extends warranty period day-for-day. A loan unit must be provided at supplier cost during major repairs.

Skills Requirements

• Local Service Infrastructure: Bidder must maintain a fully equipped, verifiable service and repair facility within KwaZulu-Natal.
• Technical Expertise: On-site technicians must be original equipment manufacturer (OEM)-trained, capable of providing rapid response (within 24 hours), and maintain adequate staffing ratios relative to installed equipment.
• Advanced Training Capability: Supplier must deliver comprehensive training to hospital staff and provincial Health Technology Services technicians, extending to printed circuit board (PCB) level diagnostics, calibration, and component-level repair.
• Regulatory & Project Management: Demonstrated capacity to navigate SAHPRA licensing, coordinate multi-stage acceptance testing, manage logistics within strict delivery windows, and ensure ongoing software/hardware upgrade compliance.

Unusual or Complicated Terms & Conditions

• HTS Specification E 261B: A rigid provincial health department template requiring clause-by-clause compliance declarations. Abbreviated responses, missing answers, or document alterations will result in immediate disqualification.
• SAHPRA Licensing: Mandatory proof of authorization from the South African Health Products Regulatory Authority to legally import, manufacture, or distribute medical devices in South Africa.
• PCB-Level Technician Training: Requires suppliers to train public sector engineers in micro-component repair and schematic analysis, far exceeding standard clinical device maintenance protocols.
• Loan Unit Obligation: Suppliers must provide a fully functional replacement unit at their own expense whenever the primary device is removed for servicing, ensuring uninterrupted clinical operations.
• Physical Sample Submission: Evaluation includes a mandatory Stage 4 requiring bidders to submit a physical demonstration unit by the closing date. Failure to present the sample results in automatic disqualification.
• Preferential Procurement (80/20 System): Scoring allocates 80 points to price and 20 points specifically to South African-owned enterprises, verified through CIPC ownership certificates and the Central Supplier Database (CSD).