Overview

The KwaZulu-Natal Department of Health, through its Central Supply Chain Management unit, invites quotations for the supply and delivery of 12-channel ECG (Electrocardiograph) machines. This is a once-off procurement for two (2) units, to be delivered to King Dinuzulu Hospital. The quotation also includes a three-year Preventative Maintenance and Service Agreement for the supplied units, which is to commence upon the expiry of the guarantee/warranty period.

Objectives

The primary objective is to procure new, modern, and fully functional 12-channel ECG recorders for use in regional and tertiary hospitals. The equipment must be suitable for both adult and paediatric patients and must include interpretive analysis capabilities. The procurement aims to ensure the supply of reliable, safe, and high-quality medical devices, complete with comprehensive training, documentation, and after-sales support, including a 24-month guarantee and a subsequent 3-year maintenance plan.

Scope of Work and Key Deliverables

• Supply and Delivery: Delivery of two (2) units of 12-channel ECG machines, including all necessary standard accessories (e.g., patient cables, mains cable, reusable suction and limb clamp electrodes, and training materials) to enable immediate operation.
• Installation and Commissioning: The successful bidder must deliver, install, test, calibrate, and commission the equipment at the specified hospital. This includes demonstrating the product to applicable staff.
• Training: Provision of end-user training for hospital staff and advanced technical training for the Department's Health Technology Services (HTS) in-house technicians. The technical training must be to the level of the manufacturer's original factory training, down to PCB (Printed Circuit Board) level, and must result in a Certificate of Competency.
• Documentation: Supply of two (2) copies each of complete user operation/maintenance manuals and original service/repair manuals in English, including circuit diagrams, calibration guides, and part numbers. All necessary software and passwords for troubleshooting and maintenance must also be provided.
• Maintenance Agreement: A fully costed Preventative Maintenance and Service Agreement for a period of three (3) years, commencing after the guarantee period, with an option for renewal.

Technical Requirements

The detailed specification (H.T.S. No E 144) outlines mandatory technical features. Bidders must confirm compliance with each clause. Key requirements include:

• Core Functionality: A portable, user-friendly 12-channel ECG recorder with a thermal dot matrix printhead, capable of recording 3, 6, and 12-lead configurations via a 10-lead patient cable.
• Display and Interface: A built-in display capable of showing text and graphics for a minimum of three ECG waveforms. The control panel must indicate which lead is being recorded.
• Recording and Data: Hard copy output on A4 size, Z-fold paper. The device must have selectable paper speeds (5, 25, and 50 mm/s), a QRS sound selector, and mains/muscle filtering. It must be able to annotate device settings, date, time, and patient name on the recording.
• Power and Portability: The unit must be lightweight and operate on both 220V AC power and an internally fitted rechargeable battery. Bidders must state the battery type, capacity, and maximum operating time.
• Memory and Upgradability: The unit must have internal memory to store ECGs and a facility to transmit data to an external device. It must be software-upgradable to perform arrhythmia mode, evaluation, and interpretation.
• Safety and Standards: The equipment must comply with international electrical safety standards (IEC 60601-1 and 60601-2), be CE Certified, and comply with the Occupational Health and Safety Act and S.A.N.S. wiring codes. It must be protected against Electro Magnetic Interference and have internal protection against defibrillator discharges (400J).
• Service Mode: The unit must have a service mode enabling technicians to test important parameters without stripping the unit.

Skills and Service Requirements

• Local Service Facility: The bidder must have a well-established service and repair facility in KwaZulu-Natal. If subcontracted, a signed letter of appointment and acceptance must be submitted.
• Qualified Technicians: Technicians must be in the direct employ of the bidder or a subcontractor and must be trained by the original equipment manufacturer (OEM). Proof of OEM training must be submitted. A technician must be available within 24 hours to attend to malfunctioning equipment.
• Spares and Support: Bidders must state the delivery period for spare parts and provide a list of spares held locally in KwaZulu-Natal. Spares must be available for 10 years. A firm commitment to supply spares, technical support, and ongoing training throughout the equipment's life cycle is required.
• Guarantee and Warranty: A minimum 24-month guarantee on all equipment, materials, and workmanship is required. The guarantee period only takes effect upon successful commissioning and acceptance by HTS. Downtime during the guarantee period must extend the guarantee on a day-to-day basis.

Evaluation Criteria

The quotation will be evaluated in three stages:

1. Stage 1: Administrative Compliance and Mandatory Requirements: This includes submission of all required forms (e.g., SBD4, SBD 6.1), company registration documents, CSD registration, OEM brochures, a letter of undertaking if not the OEM, a certified copy of the Radiation Control License, and SAHPRA certification. Failure to comply results in disqualification.
2. Stage 2: Technical Evaluation: The offered equipment must fully comply with or exceed all clauses in the technical specification. Bidders must provide detailed responses and supporting literature.
3. Stage 3: Price and Preference Points: The 80/20 preference point system applies. Points are allocated as follows: 80 points for price and 20 points for specific goals. The specific goal is race, with full points allocated to companies that are at least 100% owned by Black Africans. Proof of ownership (e.g., CIPC certificate) is required to claim these points.