Objectives

The primary objective is to supply, deliver, install, commission, and provide comprehensive training for one new nuclear medicine dose calibrator system at Victoria Mxenge Hospital. The equipment will enable accurate measurement of diagnostic and therapeutic radiopharmaceutical activities to support routine clinical nuclear medicine procedures.

Scope of Work

• Supply and delivery of a complete, fully functional dose calibrator system and all mandatory accessories.
• On-site installation, testing, initial calibration, and commissioning within the designated hot laboratory.
• Acceptance testing and performance verification conducted alongside departmental medical physicists.
• Structured training for clinical staff, radiographers, and medical physics personnel.
• Provision of a minimum 24-month comprehensive warranty covering all labour, spare parts, travel, and regulatory QA testing.
• Submission of a fully costed, comprehensive maintenance and service agreement for five years commencing immediately after the warranty period.
• Guarantee of loan units during repairs and assured spare parts availability for ten years post-delivery.

Technical Requirements

• Core Instrumentation: Well-type pressurized ionization chamber capable of measuring low and high-energy gamma-emitting radionuclides across a wide activity range, featuring high stability, low leakage current, and automatic background subtraction.
• Radionuclide Compatibility: Pre-programmed calibration factors for standard isotopes (e.g., Tc-99m, F-18, I-123, I-131, Ga-68, Lu-177) with support for user-defined factors.
• User Interface: Digital display showing activity in Becquerels (Bq) and Curies (Ci), menu-driven navigation, and real-time stable averaging.
• Data & Connectivity: USB or Ethernet port for measurement data export, with included calibration, maintenance, and troubleshooting software provided at no additional cost.
• Regulatory & Safety Compliance: Must hold valid CE certification, comply with IEC 60601-1 and 60601-1-2 standards, meet SAHPRA registration requirements, and adhere to the Occupational Health and Safety Act and SANS wiring codes.
• Physical & Environmental Specs: Hospital-grade mains cable (minimum three metres), electromagnetic interference shielding, and compliance with national radiation safety guidelines.
• Documentation: Two complete sets (physical and digital) of user and service manuals, including circuit schematics, PCB layouts, fault-finding guides, and factory test/calibration certificates.

Skills & Service Requirements

• Supplier must operate an established service and repair facility within KwaZulu-Natal.
• Field technicians must be Original Equipment Manufacturer (OEM) certified, permanently stationed in KZN, and available within 24 hours for critical breakdowns.
• Deliver advanced training to Health Technology Services in-house engineers down to the Printed Circuit Board (PCB) diagnostic level, matching manufacturer factory standards, and issue a Certificate of Competency upon completion.
• Conduct hands-on demonstrations for end-users and departmental technicians prior to formal acceptance.
• Maintain verifiable local spare parts inventory in KZN and commit to lifelong technical support and software/hardware upgrade notifications.
• Where applicable, hold a valid Radiation Control licence and demonstrate compliance with the Hazardous Substances Act.

Notes on Unusual or Complicated Terms

• Dose Calibrator: A specialized nuclear medicine device that uses a pressurized ionization chamber to precisely quantify radioactive drug doses before patient administration, ensuring therapeutic efficacy and radiation safety.
• PCB-Level Training: Advanced technical instruction focusing on electronic diagnostics, component-level repair, and schematic interpretation, rather than basic operational familiarization.
• 80/20 Preference Point System: A South African public procurement evaluation framework awarding 80 points for competitive pricing and 20 points for socio-economic transformation goals, primarily targeting 100% South African-owned enterprises.
• SAHPRA & National Nuclear Regulator Compliance: Mandatory statutory frameworks governing the legal import, distribution, and safe clinical deployment of medical devices and radiation-emitting equipment in South Africa.