Objectives

The primary objective of this tender is to procure 75 units of the Kiwi Omnicup, a complete, integrated, single-use vacuum-assisted fetal delivery device designed to facilitate fetal extraction during operative vaginal deliveries. The device aims to provide controlled traction and rotation, ensuring safe management of delivery complications, and must meet specified technical and safety standards.

Scope

The scope encompasses the supply of the Kiwi Omnicup devices to King Dinuzulu Hospital, KwaZulu-Natal, including compliance with detailed technical specifications, submission of samples/brochures, and adherence to procurement policies. The procurement process involves evaluation of technical compliance, price, and preference points, with mandatory submission of documentation and samples for assessment.

Technical Requirements

• Complete, integrated, single-use vacuum-assisted fetal delivery device suitable for all operative vaginal delivery presentations.
• Rigid, low-profile plastic cup with a flat-bottom design; nominal diameter of 60 mm (± 2 mm) and depth of 20 mm (± 2 mm).
• Ultra-low profile flexible traction stem allowing 360-degree rotation and unrestricted placement.
• Hand-operated, self-contained PalmPump™ mechanism with integrated pressure/traction force indicator.
• Instantaneous tactile vacuum release button on the pump handle.
• Supplied sterile, individually blister-packed, for single-use to prevent cross-contamination.
• Device must be CE marked, ISO 13485 certified, and have a valid SAHPRA Medical Device Establishment Licence for Class B/C devices.
• Packaging of 5 units per box, with a total of 75 units requested.
• Sample or detailed brochure submission required with the quotation.

Skills and Documentation Requirements

• Completion and submission of all mandatory forms, including the Price Page, Bidder’s Disclosure (SBD4), Preference Points Claim Form, and Specification Form.
• Provision of a valid B-BBEE certificate or sworn affidavit for EMEs & QSEs.
• Submission of a Central Supplier Database (CSD) compliance report.
• Declaration of interest and disclosure of any relationships with Department of Health employees or related enterprises.
• Submission of samples/brochures, with the sample being available for inspection if requested.
• Compliance with technical specifications, including attaching a signed specification form by the end-user and SCM representative.
• Adherence to procurement policies, including VAT registration (if applicable), tax clearance, and certification of compliance documents.