Objectives

The primary objective is to procure a single portable gamma probe sentinel system for surgical application at Dr Pixley Ka Isaka Seme Memorial Hospital. The tender seeks to secure a compliant, high-performance medical device that enables precise intraoperative identification of sentinel lymph nodes and parathyroid glands, while ensuring long-term technical reliability, regulatory adherence, and comprehensive staff competency development.

Scope

The scope covers the complete supply, delivery, installation, and commissioning of one gamma probe system. It includes provision of a starter pack with essential disposables, dual copies of user and technical documentation, calibration software, and mandatory clinical and technology staff demonstrations. The contract mandates a minimum twenty-four-month warranty encompassing all maintenance, spare parts, travel, and regulatory quality assurance testing. Following warranty expiry, the successful bidder must provide a fully costed two-year comprehensive maintenance and service agreement with renewal options. Bidders are required to submit a physical sample for evaluation and demonstrate established local service capability within KwaZulu-Natal.

Technical Requirements

• Device Specifications: Portable, lightweight, and robust unit featuring a cabled CdTe probe, automatic isotope windowing (Tc-99m, I-125, I-131, F-18), zero calibration drift, rapid counting capabilities, certified sterilization protocols, and a minimum eight-hour internal battery life.
• Compliance & Safety: Valid SAHPRA distribution licensing, CE certification, and adherence to IEC 60601-1/2 electrical safety standards, Occupational Health and Safety Act, and SANs wiring codes. Electromagnetic interference protection is mandatory.
• Documentation & Software: Dual sets of user and service manuals containing schematics, PCB layouts, fault-finding guides, and part numbers. Full troubleshooting and calibration software, plus dedicated test tooling, must be supplied.
• Support & Logistics: Established KwaZulu-Natal service facility with original equipment manufacturer (OEM)-trained technicians, guaranteed twenty-four-hour response time, ten-year spare parts availability, and provision of a loan unit during repairs.
• Warranty & Maintenance: Twenty-four-month guarantee covering all labour, components, travel, and Radiation Control Board quality assurance testing. Equipment downtime automatically extends the warranty period. A subsequent two-year comprehensive maintenance contract is compulsory.
• Evaluation Criteria: Physical sample submission required. Pricing must remain firm for one hundred eighty days, inclusive of VAT. Evaluation follows an 80/20 preference point system prioritising price and South African ownership.

Skills Requirements

• Advanced Technical Expertise: Bidders must employ or contract OEM-certified technicians capable of delivering PCB-level diagnostic and repair training to hospital engineering staff.
• Regulatory & Clinical Knowledge: Demonstrated proficiency in SAHPRA medical device distribution regulations, radiation control compliance, and international healthcare equipment safety standards.
• Local Service Infrastructure: Proven operational capacity within KwaZulu-Natal to execute rapid deployment, calibration, and sustained technical support without external international dependency.
• Project Coordination: Capability to manage installation, commissioning, clinical demonstrations, and structured training programmes while adhering to strict delivery and acceptance timelines.

Explanation of Unusual or Complicated Terms

• Gamma Probe Sentinel: A specialised intraoperative handheld device that detects trace radioactivity from injected tracers to map lymphatic drainage pathways, allowing surgeons to locate sentinel lymph nodes and parathyroid glands with minimal tissue disruption.
• SAHPRA Licensing: Mandatory authorisation from the South African Health Products Regulatory Authority confirming the device meets national safety, efficacy, and quality standards for legal medical distribution in South Africa.
• PCB-Level Training: Advanced technical instruction covering printed circuit board diagnostics, component-level replacement, and electronic repair, extending beyond basic operator training to equip hospital engineers with deep maintenance capabilities.
• 80/20 Preference Point System: A South African public procurement evaluation framework allocating eighty percent of scoring weight to price competitiveness and twenty percent to socio-economic goals, specifically favouring South African-owned enterprises in this tender.