Objectives

The primary objective is to procure, supply, and commission one portable Holter ECG monitor for diagnostic use at Ngwelezane Hospital. The acquisition aims to enhance the department’s capacity to continuously monitor and analyse cardiac arrhythmias through reliable ambulatory electrocardiography.

Scope

This is a once-off supply contract for a single unit. The scope encompasses delivery, installation, clinical demonstration, commissioning, and formal acceptance testing at the designated hospital. The supplier must provide a complete starter pack of accessories and disposables to ensure immediate operational readiness. Additionally, the contract mandates a fully comprehensive maintenance and service agreement extending five years beyond the initial warranty period, alongside structured technical training for hospital personnel.

Technical Requirements

• Device must be a portable, battery-operated (AA alkaline) Holter recorder capable of 3-channel continuous ECG recording for 24–48 hours.
• Features high-resolution digital storage using removable media, automatic gain adjustment, and compatibility with existing hospital networks and Windows-based analysis workstations.
• Must include a lockable lid, lightweight ergonomic casing, patient-isolated communication link, and a minimum 17-inch LCD display.
• Compliant with international electrical safety standards (IEC 60601-1/60601-1-2), CE certified, and equipped with a hospital-grade, SANs colour-coded mains cable (minimum 3 metres).
• Must supply complete user and service/repair manuals, calibration software, troubleshooting tools, and spare parts availability guaranteed for ten years.
• Initial warranty minimum of twenty-four months; comprehensive service agreement for five additional years covering all labour, travel, spares, breakdowns, and routine maintenance.
• Equipment must be new, latest-generation technology, and accompanied by physical samples prior to submission.

Skills Requirements

• Suppliers must maintain an established local service and repair facility within KwaZulu-Natal, with technicians available within twenty-four hours of malfunction reporting.
• Technical staff must be original equipment manufacturer (OEM) trained to perform service, repair, and calibration down to the printed circuit board (PCB) level.
• The successful bidder must deliver formal, factory-equivalent training to hospital health technology technicians, culminating in a Certificate of Competence within three months of delivery.
• Ongoing technical support, software updates, and provision of dedicated test equipment and special tooling upon request are mandatory.

Notable Terms & Conditions

Fully Comprehensive Maintenance Agreement: A five-year post-warranty contract where the supplier bears all costs for scheduled maintenance, emergency call-outs, spare parts, labour, and travel. Detailed costing per activity must be submitted separately.

Loan Unit Provision: If the primary unit is removed for repairs, a fully functional loan set must be supplied at no extra cost until the original unit is returned.

Regulatory Compliance: Bidders must hold a valid South African Health Products Regulatory Authority (SAHPRA) licence for medical device distribution and comply with the Hazardous Substances Act where applicable.

Preference Points: Evaluation uses an 80/20 scoring system, with twenty points allocated specifically to promote South African-owned enterprises, verified via Central Supplier Database (CSD) records.