Mini C Arm Fluoroscopy System for Plastic, Reconstructive and Hand Surgery

AI-generated analysis of the documents. Check the official notice and any amendments for current submission details.

1. At a glance

2. Scope of Work

St. Vincent's University Hospital requires the supply of a compact, mobile mini C-arm fluoroscopy system for intra-operative use in its Plastic, Reconstructive & Hand Surgery Operating Theatre. The system is intended for high-volume extremity trauma and reconstructive procedures, including metacarpal/phalangeal fracture fixation, K-wire/screw placement, fracture reduction assessment, and implant positioning. The primary function is to provide precise, real-time imaging of small bones, joints, and hardware within a confined sterile field, minimising the need for repositioning and reducing radiation exposure.

The scope of supply encompasses:

• Supply of the Mini C-Arm Fluoroscopy System: This includes the core unit, which must be compact and mobile.
• Key System Features:
• Field of View (FoV): Must be capable of visualising the entire adult hand in a single field of view, with a minimum size of ≥20 x 20 cm.
• Generator: Must feature a pulsed generator.
• Detector: Must incorporate a large flat-panel detector.
• Imaging Capabilities: Must deliver pulsed fluoroscopy with adjustable low-dose modes and automatic exposure control.
• Integration and Compliance:
• PACS/NIMIS Integration: Must ensure seamless integration with existing NIMIS/PACS systems.
• User Operation: Must be designed for practitioner operation.
• Radiation Safety: Must be fully compliant with EU radiation protection directives.
• Infection Control: Must comply with St. Vincent's University Hospital's infection-control standards.
• Ancillary Services:
• Delivery: To St. Vincent's University Hospital.
• Installation: Of the system.
• Commissioning: To ensure full operational status.
• Training: For relevant personnel.
• Warranty: A minimum 24-36 month comprehensive warranty, including parts, is required.
• Optional Extended Maintenance: Provision for optional extended maintenance is sought.
• Spare Parts: Availability of spare parts and a commitment to supply parts for a minimum of ten (10) years from the date of installation is mandatory.

The system is intended for exclusive intra-operative use within the specified operating theatre.

3. Background & buyer context

St. Vincent's University Hospital (SVUH) is procuring a Mini C-Arm Fluoroscopy System to enhance its Plastic, Reconstructive & Hand Surgery service. This procurement aligns with the hospital's ongoing efforts to modernise its surgical equipment and improve patient care by providing advanced imaging capabilities for complex procedures. The service performs a high volume of extremity trauma and reconstructive surgeries, necessitating precise, real-time imaging for optimal outcomes. The acquisition of a dedicated mini C-arm is deemed essential to meet the specific imaging demands of these procedures, ensuring compliance with radiation safety standards and hospital infection-control protocols. The tender is conducted under an open procedure, adhering to the European Union (Award of Public Authority Contracts) Regulations 2016.

4. Eligibility & selection criteria

Tenderers must meet the following criteria to be considered for evaluation:

• Turnover requirement:
• Minimum average annual turnover of €500,000 per financial year for the last three financial years, or pro rata if established later.
• Insurance:
• Employer’s Liability: €12.7 million for any one claim or series of claims.
• Public Liability: €6.5 million for any one claim or series of claims.
• Product Liability: €6.5 million for any one claim or series of claims.
• Certifications:
• CE marking and compliance with European Medical Device Regulation (EU MDR) 2017/745.
• Full compliance with relevant European and Irish radiation safety standards/legislation.
• Past experience:
• Not specified for this tender.
• Personnel:
• Not specified for this tender.
• Geographic / facility constraints:
• Not specified for this tender.

Tenderers must also declare, via the eESPD, the absence of mandatory grounds for exclusion or demonstrate sufficient reliability if exclusion grounds apply. They must also satisfy the selection criteria as set out in the tender documents.

5. Award criteria & scoring

The contract will be awarded based on the most economically advantageous tender (MEAT). The total marks available are 10,000, allocated as follows:

Criterion Weighting Marks Sub-criteria