Tender Summary

Objectives

The primary objective is to procure, deliver, install, commission, and train personnel on a single advanced cardiac output monitor for use in an Intensive Care Unit. The system must enable continuous haemodynamic monitoring via arterial waveform analysis, calibrated intermittently by transpulmonary thermodilution, to support critical care decision-making.

Scope

• Delivery & Installation: Supply of one new, latest-model unit, including all non-disposable peripherals, a starter pack of disposables, and a mobile roll stand. Full delivery, installation, testing, calibration, and commissioning at the designated hospital site.
• Training: Comprehensive instruction for Department of Health Health Technology Services technicians and clinical end-users, concluding within three months of delivery.
• Warranty & Support: Minimum twenty-four-month guarantee covering all labour, spares, travel, and radiation control board QA testing. Provision of a loan unit during repairs and commitment to long-term spare parts availability for ten years.
• Documentation & Software: Provision of two complete sets of user and original service manuals (including schematics, PCB layouts, and calibration guides), plus full calibration/maintenance software, troubleshooting tools, and system passwords.

Technical Requirements

• Form Factor: Standalone device or ICU-compatible module with a ≥10-inch colour touchscreen, graphical/numerical display, and bedside suitability.
• Power: 220V AC 50Hz operation with an internal rechargeable battery providing ≥30 minutes of uninterrupted monitoring during power failure.
• Monitoring Technology: Continuous arterial-waveform-based haemodynamic tracking using pulse contour or pulse power analysis. Intermittent calibration via transpulmonary thermodilution. No pulmonary artery catheter required.
• Measured Parameters: Cardiac output, stroke volume, stroke volume variation, systemic vascular resistance, contractility index, global end-diastolic volume index, and extravascular lung water.
• Data & Alarms: ≥24-hour trend storage/display, digital alarm system with adjustable limits and priority coding, USB/network data export, and hospital information system integration capability.
• Compliance: CE certification, SAHPRA registration, compliance with IEC 60601-1/60601-1-2 electrical safety standards, Occupational Health and Safety Act, and SANS wiring codes.
• Upgrades & Lifecycle: Free patient-safety-related software/hardware upgrades, clear upgrade policy disclosure, and demonstration of peer-reviewed clinical performance validation.

Skills Requirements

• Local Service Infrastructure: Established repair, calibration, and stocking facility within KwaZulu-Natal. Direct OEM-trained technicians must be available within 24 hours of malfunction reports.
• Advanced Technician Training: In-depth training for DoH technicians covering calibration, maintenance, and repair down to Printed Circuit Board (PCB) level. Training must match manufacturer factory standards and culminate in a Certificate of Competency.
• Proof of Qualification: Submission of OEM training certificates for all servicing staff, documented technician-to-installation ratios, and verifiable local spare parts inventory.
• Service Commitment: Written confirmation of ongoing technical support, spare parts supply, and lifecycle management for the duration of the equipment's operational life.

Key Terminology Explanation

Transpulmonary Thermodilution: A minimally invasive measurement technique where cold saline is injected into a central vein, and temperature changes are tracked in an arterial line to calculate cardiac output and fluid volumes without inserting a catheter into the pulmonary artery.

Haemodynamic Parameters: Quantitative measurements of blood flow, pressure, and volume within the cardiovascular system, essential for managing critically ill patients with shock, heart failure, or sepsis.

PCB Level Repair: Advanced diagnostic and repair work involving individual electronic components on circuit boards, requiring specialized engineering expertise beyond standard module or unit replacement.

SAHPRA Registration: Mandatory approval by South Africa’s health products regulatory authority, ensuring medical devices meet national safety, quality, and efficacy standards before clinical deployment.