The subject of the procurement is the rental service of a robot-assisted system for orthopedic surgery, along with necessary equipment, instruments, and service support for a period of 4 years from the date of mutual signing of the Agreement.

The system must be fully compliant with the technical specifications outlined in the cost estimate, functional, and ready for clinical use.

The offer must include at least:

• installation and commissioning of the system,
• provision of necessary instruments and consumables for the operation of the system,
• the system must be fully functional for performing surgical procedures for the implantation of partial knee prostheses. The bidder is obliged to ensure that all necessary software modules, licenses, and functionalities for the specified type of procedure are included in the offered price, without additional costs and without usage limitations throughout the duration of the contract,
• the service package during the rental period includes software updates to the latest available version at no extra charge, provision of all necessary service and technical documentation, and resolution of technical problems with the expert assistance of authorized technicians. It also includes the development and implementation of a regular and extraordinary maintenance plan, provision of spare parts necessary for optimal operation of the system, and coverage of transportation and technician labor costs. The bidder must ensure a technician response within 24 to 48 hours from the first contact, ensuring continuous technical support and maintenance of the system's functionality with minimal interruptions throughout the duration of the contract.

All offered equipment must be fully compliant with the cost estimate and prescribed technical specifications, as well as all other conditions specified in this procurement documentation. Bidders are required to offer fully functional, new, unused, and undamaged equipment, with the offered price including all costs, including but not limited to supply, delivery, installation, testing, commissioning, staff training for proper operation and use on the Client's premises, as well as all costs of the service package during the rental period. The service package includes regular and extraordinary maintenance, software updates, provision of necessary spare parts and consumables, technical support, and all other related costs necessary for the uninterrupted and continuous operation of the system throughout the entire rental period.

The subject of the rental must be fully compliant with the applicable regulations of the Republic of Croatia and the European Union that govern healthcare and medical devices, including but not limited to the Health Care Act, the Medical Devices Act, Regulation (EU) 2017/745 on medical devices (MDR), and all corresponding subordinate legislation and technical standards.

LOT-0000
Procurement of a Robot-Assisted System for Orthopedics.
The subject of the procurement is the rental service of a robot-assisted system for orthopedic surgery, with the associated equipment, instruments, and service support. The procedure is conducted to conclude a framework agreement for a period of 4 years, based on which individual annual public procurement contracts will be concluded.

The offered system must be fully compliant with the technical specifications, functional, and ready for clinical use.

The offer must include at least:

• installation and commissioning of the system,
• provision of necessary instruments and consumables for the operation of the system,
• the system must be fully functional for performing surgical procedures for the implantation of partial knee prostheses. The bidder is obliged to ensure that all necessary software modules, licenses, and functionalities for the specified type of procedure are included in the offered price, without additional costs and without usage limitations throughout the duration of the contract,
• the service package during the rental period includes software updates to the latest available version at no extra charge, provision of all necessary service and technical documentation, and resolution of technical problems with the expert assistance of authorized technicians. It also includes the development and implementation of a regular and extraordinary maintenance plan, provision of spare parts necessary for optimal operation of the system, and coverage of transportation and technician labor costs. The bidder must ensure a technician response within 24 to 48 hours from the first contact, ensuring continuous technical support and maintenance of the system's functionality with minimal interruptions throughout the duration of the contract.

All offered equipment must be fully compliant with the cost estimate and prescribed technical specifications, as well as all other conditions specified in this procurement documentation. Bidders are required to offer fully functional, new, unused, and undamaged equipment, with the offered price including all costs, including but not limited to supply, delivery, installation, testing, commissioning, staff training for proper operation and use on the Client's premises, as well as all costs of the service package during the rental period. The service package includes regular and extraordinary maintenance, software updates, provision of necessary spare parts and consumables, technical support, and all other related costs necessary for the uninterrupted and continuous operation of the system throughout the entire rental period.

The subject of the rental must be fully compliant with the applicable regulations of the Republic of Croatia and the European Union that govern healthcare and medical devices, including but not limited to the Health Care Act, the Medical Devices Act, Regulation (EU) 2017/745 on medical devices (MDR), and all corresponding subordinate legislation and technical standards.

Note: Exclusively for capacity planning and organization purposes, the Client estimates that the system will be used for approximately 150 procedures annually. This data is for information purposes only and serves solely as an approximate estimate of the expected usage scope, without the Client being obligated to realize the specified number of procedures. The actual number of procedures may vary from the specified estimate depending on the Client's needs.