Tender Summary: Supply and Deliver Dose Calibrator

Objectives

The primary objective is to procure, supply, and deliver one (1) new nuclear medicine dose calibrator system to Victoria Mxenge Hospital. The procurement aims to establish a reliable, compliant, and clinically accurate measurement tool for diagnostic and therapeutic radiopharmaceuticals, thereby supporting routine nuclear medicine operations while adhering to national health technology, safety, and regulatory standards.

Scope of Work

The successful supplier will manage the complete lifecycle provision of the equipment, including:

• Supply, delivery, installation, and commissioning of a fully functional dose calibrator system.
• Performance of acceptance testing, initial calibration, and constancy verification per international guidelines.
• Provision of a minimum 24-month comprehensive guarantee covering all spares, labour, travel, scheduled maintenance, and QA testing.
• Delivery of a starter pack containing all essential accessories and disposables for immediate clinical operation.
• Comprehensive on-site training for nuclear medicine radiographers, medical physicists, and hospital engineering technicians.
• Submission of a fully costed, comprehensive maintenance and service agreement for five (5) years post-guarantee, with renewal options.
• Provision of loan units during equipment repairs and a lifelong commitment to spare parts, software updates, and technical support.

Technical Requirements

The equipment must satisfy rigorous clinical, safety, and operational specifications:

• Core Technology: A well-type pressurized ionization chamber system designed for accurate measurement of low and high-energy gamma-emitting radionuclides, featuring automatic background subtraction, high stability, and low leakage current.
• Radionuclide Compatibility: Pre-programmed calibration factors for standard isotopes (including Technetium-99m, Fluorine-18, Iodine-123/131, Gallium-68, and Lutetium-177), with support for user-defined factors.
• Interface & Connectivity: Digital display in Becquerels (Bq) and Curies (Ci), intuitive menu-driven controls, real-time stable averaging, and USB/Ethernet interfaces for data export and archiving.
• Safety & Compliance: Must comply with IEC 60601-1 and IEC 60601-1-2 medical electrical standards, hold valid CE certification, be registered with SAHPRA, and meet South African Occupational Health and Safety wiring codes. Equipment must be brand new, latest-model technology.
• Documentation & Software: Two sets each of user and detailed service/repair manuals (including circuit diagrams, PCB layouts, fault-finding guides, and exploded mechanical diagrams), plus all calibration software, troubleshooting tools, and access passwords at no additional cost.
• Service Infrastructure: Bidders must maintain a local service facility in KwaZulu-Natal, guarantee a 24-hour technician response time, and demonstrate adequate local spare parts inventory.

Skills and Service Requirements

Suppliers must demonstrate advanced technical, operational, and regulatory capabilities:

• Certified Technical Expertise: All servicing personnel must be original equipment manufacturer (OEM)-trained to diagnose, repair, and calibrate the specific model, including down to the printed circuit board (PCB) level.
• Training Delivery: Ability to conduct structured on-site training programs for clinical and engineering staff, culminating in issued Certificates of Competency within three months of delivery.
• Regulatory & Clinical Knowledge: Proficiency in radiation safety protocols, quality assurance testing aligned with International Atomic Energy Agency (IAEA) guidelines, and compliance with National Nuclear Regulator requirements.
• Project Management: Proven capacity to coordinate logistics, installation, commissioning, and acceptance testing within agreed timelines without disrupting hospital operations.
• After-Sales Support: Establishment of a dedicated after-hours backup service facility and a systematic approach for notifying users of software updates, modifications, recalls, and future upgrade policies.

Key Terms Explained

• Dose Calibrator: A specialized nuclear medicine instrument used to measure the precise radioactivity of radiopharmaceuticals before patient administration, ensuring accurate diagnostic imaging and targeted cancer therapies.
• Well-Type Ionization Chamber: The detector design used in these devices, consisting of a cylindrical cavity that surrounds the sample container to maximize radiation detection efficiency and measurement accuracy.
• PCB-Level Training: Advanced technical instruction enabling hospital engineers to troubleshoot and repair electronic components directly on the device’s internal circuit boards, significantly reducing downtime and external manufacturer dependency for minor faults.