Objectives

The primary objective of this tender is to procure a Hand Held Manual Vacuum Aspirator that meets specified standards and technical requirements for use at Wentworth Hospital, KwaZulu-Natal. The procurement aims to acquire a device suitable for facilitating birth in the second stage of labour, ensuring safety, efficiency, and compliance with relevant standards.

Scope

The scope of the tender encompasses the supply of a single-use, hand-held manual vacuum delivery system, including all necessary specifications, accessories, and documentation. It covers the entire procurement process from submission, evaluation, to delivery and commissioning at Wentworth Hospital. The scope also includes adherence to specified technical standards, compliance with procurement policies, and the provision of samples and supporting documentation as required.

Technical Requirements

The technical specifications for the manual vacuum aspirator include:

• Single-use disposable device designed for vacuum-assisted fetal delivery.
• Vacuum generator capable of reaching approximately 600mm Hg.
• Vacuum release time not exceeding 3 seconds.
• Soft sponge interface to apply to the baby's head.
• Traction force indicator to measure and display the amount of traction applied.
• Harder cups to distribute pressure and suction effectively.
• Flexible stem for better maneuverability in various positions (OP, OA, OT).
• Measurement increments indicating the depth of cup insertion.
• Vacuum gauge with color-coded readings for immediate assessment.
• Hand pump for easy vacuum creation and control.
• Compliance with SASA approved quality standards.
• Sample required for evaluation and testing.
• Attached picture of the complete vacuum delivery system as part of the specification.

Additional Technical Notes

The device must be manufactured according to relevant standards such as EN ISO 13485:2016, CE Class IIa, FDA 510(k) number K981260, and EU Directive 93/42/EEC, Annex II. It should incorporate features for safety, ease of use, and mechanical efficiency, including:

• Accurate traction indicator (±25% of range).
• Reliable vacuum generation and gauge accuracy (±10% of range).
• Durable, soft interface sponge for patient comfort.
• Design facilitating proper distribution of pressure and suction.
• Ease of operation with a control hand pump.
• Disposable, eliminating reprocessing and potential damage or loss of parts.

Summary

The technical requirements specify a safe, effective, and compliant manual vacuum aspirator with precise vacuum control, safety indicators, and disposability, suitable for clinical use in obstetric procedures at Wentworth Hospital.