Objectives

The primary objective of this tender is to establish a Service Level Agreement (SLA) for the rental of Mechanical Leg Compression Devices, including consumables, for Livingstone Tertiary Hospital. The aim is to ensure the provision, maintenance, and effective use of compression devices to prevent Venous Thromboembolism (VTE) among patients, with a focus on clinical effectiveness, safety, and operational reliability over a period of 12 months.

Scope

The scope of the tender includes:

• Provision of graded electronic leg compression devices suitable for VTE prophylaxis.
• Supply of consumables (compression garments) compatible with the devices, including different sizes (small, medium, large) with specific features such as fixed pressure inflation at 40 mmHg, cycle times, and fit for various limb sizes.
• On-site availability, installation, and maintenance of the devices, which remain the property of the supplier.
• Training hospital staff on the correct use of the equipment.
• Provision of software updates during the contract period.
• Support for technical issues, including on-call technical assistance and resolution within specified timeframes.
• Adherence to safety, quality, and certification standards, including CE and ISO certifications.
• Evaluation and demonstration of device performance, clinical support, and compliance with technical specifications.

Technical Requirements

The technical specifications for the devices include:

• Device Model: To be specified as per manufacturer brochures.
• Device must be capable of providing uniform, uninterrupted compression to the entire leg during treatment stages.
• Inflation pressure: 40 mmHg with a cycle time of 12 seconds inflation and 48 seconds deflation.
• Support for sizes up to 81cm limb circumference, with options for thigh and non-thigh garments.
• Device dimensions: approximately 230mm (height) x 300mm (width) x 60mm (depth); weight around 2kg; display resolution at least 800x600 LCD.
• Battery backup: internal battery capable of operating for 30 minutes during power failure.
• Automatic switching to battery power during mains failure, with surge protection built-in.
• Connectivity: Fixed cable connection between garment and pump to prevent accidental discarding.
• Device uptime: greater than 98% excluding scheduled maintenance.
• Compliance with CE marking, SAHPRA registration, ISO 9000 or ISO 13485 certification.
• Software updates included in rental costs.
• Device must be able to hook onto hospital beds securely.

Skills Requirements

The successful bidder must demonstrate:

• Provision of a qualified technician residing in the Nelson Mandela Metropole for on-call technical support.
• Resolution of technical failures within 48 hours.
• Experience in providing similar medical device services, supported by references and previous contracts.
• Ability to conduct comprehensive staff training on device operation at no extra cost.
• Knowledge of safety standards, device maintenance, and software management.
• Provision of manuals and technical documentation that are confidential, comprehensive, and user-friendly.
• Ability to supply optional accessories and support clinical and blood flow efficacy studies.