Objectives

The primary objective of this tender is to supply a Dual Channel Tens Machine that meets the specified technical and quality standards, ensuring effective pain management therapy for patients at Wentworth Hospital. The procurement aims to acquire equipment that complies with national and departmental specifications, including safety, performance, and compatibility requirements.

Scope

The scope encompasses the supply, delivery, installation, testing, commissioning, and training related to the Dual Channel Tens Machine as per attached specifications. It includes providing necessary accessories, manuals, and support services, with a focus on compliance with technical standards, warranty, and after-sales service within the KwaZulu-Natal region.

Technical Requirements

• The device must be a dual-channel Transcutaneous Electrical Nerve Stimulator (TENS) suitable for pain treatment.
• Independent outputs with adjustable amplitude control, with output current adjustable from 0 to 80mA peak-to-peak.
• Powered by a common disposable alkaline battery with a minimum life of 100 hours.
• Size not exceeding 10cm x 9cm x 2.6cm, preferably with belt grip.
• Provide three modes: Burst, Continuous, and Modulation, with adjustable pulse width (40-260μs) and pulse rate (2-120Hz).
• Visible indicators for ON/OFF status per channel.
• Must be FDA approved if manufactured in the USA.
• Supply re-usable electrodes (minimum size 3.8cm x 4.4cm) with renewable adhesive mounts, and two sets of connecting lead wires.
• Guarantee minimum 24 months warranty with uptime guarantee of at least 99%.
• Include all standard accessories, manuals, calibration software, and spare parts for at least 10 years.
• Comply with IEC 60601-1 and 60601-2 electrical safety standards and CE certification.
• Provide training, demonstration, and after-sales service with local repair facilities.

Skills Requirements

• Proven technical expertise in manufacturing, supplying, and servicing medical electrical equipment, specifically TENS units.
• Capability to provide comprehensive training to hospital technicians and end-users on operation, calibration, maintenance, and repair down to PCB level.
• Established service and repair facilities within KwaZulu-Natal, with qualified technicians trained by OEMs.
• Ability to supply and support spare parts, accessories, and software updates for at least 10 years.
• Experience in complying with South African and international medical device standards and regulatory requirements, including SAHPRA licensing and IEC certifications.
• Capacity to deliver, install, test, and commission equipment within the specified delivery period, with demonstrated capacity to handle technical support and maintenance.