Objectives

The tender aims to procure a Two Channel Computerized Electromyography (EMG) system, including nerve conduction and evoked potential capabilities, to be used at Greys Hospital. The objective is to acquire a modern, reliable, and fully compliant system that meets technical, safety, and operational standards to support clinical diagnostics and research within the Department of Health.

Scope

The scope encompasses the supply, delivery, installation, testing, calibration, and commissioning of a two-channel EMG system with associated hardware, software, accessories, and training. It includes providing support services such as maintenance, spare parts, and training for end-users and technical staff. The system must operate within specified technical and safety standards, be upgradeable, and support future software updates. The procurement covers all related documentation, manuals, optional accessories, and compliance with legal and safety regulations.

Technical Requirements

System Hardware

• Two (2) channel computerized EMG, nerve conduction, and evoked potential system.
• PC with minimum specifications: Dell OptiPlex Core i5 3GHz, 8GB RAM, 500GB SSD, Windows 10 64-bit.
• Color monitor (at least 23 inches), laser color printer, junction box stand, trolley, and relevant accessories.
• Expandable up to 4 channels for visual evoked potentials.

System Software & Functionality

• Support for simultaneous recording of at least 2 channels, expandable to 4.
• Multi-tasking software allowing multiple test protocols concurrently.
• Automatic waveform marking, normative data input, and real-time playback.
• Support for visual evoked potentials (VEP), electroretinogram (ERG), electrooculogram (EOG), and other evoked potentials.
• Comprehensive nerve conduction studies with automatic evaluation, latency, amplitude, and interpretation.
• Quantitative EMG analysis, MUAP pattern recognition, and single fiber EMG capabilities.
• Post-processing, review, and storage of up to 99 sites of waveform data.
• Support for artifact rejection, filtering, calibration, and temperature compensation.

Amplifiers & Signal Processing

• At least 4 electrically isolated amplifiers with input impedance >1000 MΩ.
• Low noise (<0.6 μV rms), adjustable sensitivity, and filters (low-cut, high-cut, notch).
• Automatic impedance check with numerical display.

Stimulators & Evoked Potentials

• Electrical stimulators with adjustable pulse duration (0.01 to 1 ms), synchronized operation, and remote control.
• Auditory stimulator supporting click, tone, burst modes, with adjustable intensity (0-132 dB SPL), and optional masking.
• Visual stimulus options including pattern reversal, LED goggles, external triggers, with adjustable display times (20-1000 ms).
• Repetitive stimulation capabilities with adjustable frequency and train parameters.

Safety & Compliance

• Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, and other relevant standards.
• CE certification for the equipment.
• Protection against electromagnetic interference and electrical shock (BF rated).
• Proper grounding, insulation, and safety features.
• Equipment must be supplied with a hospital-grade mains cable, minimum 3 meters long.

Support, Maintenance & Training

• Guarantee/warranty of at least 24 months, including breakdown repairs, spare parts, and software updates.
• Full training for technical staff on calibration, maintenance, repair, and troubleshooting down to PCB level.
• Established service and repair facilities within KwaZulu-Natal or authorized subcontractors with documented support.
• Provision of manuals, software, and support for the entire equipment lifecycle (minimum 10 years spares availability).
• Demonstration and acceptance testing at the hospital site prior to final acceptance.

Documentation & Manuals

• Complete user operation and maintenance manuals, service manuals, and software keys at no extra cost.
• Support for software updates, modifications, and recalls.
• Supporting brochures, technical data sheets, and evaluation reports if available.

Optional Accessories & Extras

• Quoted separately with detailed descriptions, catalog numbers, and prices including VAT.
• Additional accessories that enhance system functionality or usability.

Legal & Regulatory Compliance

• Valid license issued by the South African Health Products Regulatory Authority (SAPHRA) for manufacturing, importing, or distributing medical devices.
• Disclosures of any conflicts of interest, relationships with Department of Health staff, or previous contractual defaults.
• Adherence to procurement regulations, preference policies, and anti-corruption measures.