Objectives

The primary objective is to procure a portable Gamma Probe Sentinel system for intraoperative use in identifying sentinel lymph nodes and parathyroid glands. The procurement aims to secure a compliant, high-performance medical device that enhances surgical precision while meeting strict national safety, regulatory, and local support standards.

Scope

The contract encompasses the supply, delivery, installation, commissioning, and initial training for one (1) Gamma Probe Sentinel unit. It includes provision of a starter pack of essential accessories and disposables, comprehensive operational and service manuals, calibration software, and a mandatory 24-month warranty covering all servicing, calibration, technical support, and spare parts. Following the warranty period, a fully costed, comprehensive maintenance and service agreement for two additional years is required, with an option for renewal. The supplier must commit to supplying spare parts for ten years, providing loan units during repairs, and delivering ongoing technical support throughout the equipment’s lifecycle.

Technical Requirements

• Portability & Design: Lightweight, robust construction packaged in a durable carry case.
• Probe Specifications: Cabled probe compatible with CdTe detector; specific dimensions (SN-Angled-Small 11mm, L 197/199mm and 14mm); certified sterilization options.
• Performance Features: Auto-settings for Tc-99m, auto probe identification, large 5-digit display, PC connectivity, dual sound modes (BIP/FM), customizable configuration storage, automatic windowing for Tc-99m, I-125, I-131, and F-18, zero calibration drift, and rapid target/background counting.
• Power: Internal battery with minimum 8-hour runtime, including charger cable.
• Compliance & Safety: Must meet IEC 60601-1 & 60601-1-2 standards, hold CE certification, comply with the Occupational Health and Safety Act, SANS 0142 wiring code, and provide electromagnetic interference protection. Hospital-grade mains cable (minimum 3 metres, SANS colour-coded).
• Regulatory & Documentation: Valid SAHPRA registration/license, Radiation Control licence (or official exemption proof), and compliance with the Hazardous Substances Act if applicable. Must include two sets of user/operation manuals, two sets of original service/repair manuals (with schematics, PCB layouts, calibration guides), and all necessary calibration/maintenance software.
• Technology & Upgrades: Latest commercially available model. Patient-safety-related hardware/software upgrades and virus removals must be provided at no extra cost. Clear upgrade policy and expected lifespan documentation required.

Skills & Service Requirements

• Local Support Infrastructure: Supplier must maintain a well-established service and repair facility in KwaZulu-Natal, subject to inspection. If subcontracted, formal appointment letters and subcontractor premises details are required.
• Technician Qualifications: Permanently employed or subcontracted technicians must be OEM-trained, based in KZN, and maintain a defined technician-to-install-base ratio. A 24-hour response time for malfunctions is mandatory.
• Training & Demonstration: Comprehensive training for end-users and in-house Health Technology Service technicians down to PCB level, equivalent to manufacturer factory training. A Certificate of Competency must be issued upon completion. Demonstrations are required during the test and acceptance phase.
• Acceptance & Lifecycle Support: Equipment must undergo formal acceptance testing with Health Technology Services and Hospital Management. Supplier must establish a notification system for updates, modifications, software releases, and recalls, alongside continuous technical support throughout the equipment’s lifecycle.

Notes on Unusual or Complicated Terms

• Gamma Probe Sentinel System: A specialized nuclear medicine device used intraoperatively to detect trace amounts of radioactive isotopes, enabling surgeons to locate sentinel lymph nodes or abnormal parathyroid tissue with minimal invasiveness. Requires precise radiation detection capabilities and strict regulatory oversight.
• PCB-Level Training: Advanced technical instruction requiring personnel to diagnose, calibrate, and repair printed circuit boards, extending beyond basic operational training to full hardware maintenance competency.
• Health Technology Services (HTS) Clinical Evaluation: A government-mandated assessment where technical and clinical experts trial the equipment to verify functionality, performance, and suitability before final bid adjudication.
• 80/20 Preferential Procurement System: A South African public procurement framework allocating 80 points for competitive pricing and 20 points for socio-economic goals, specifically prioritising South African-owned enterprises.