The subject of the contract is the purchase and successive delivery to the headquarters of the Institute:
Part 1 - microelectrodes for microrecording during DBS implantation procedure included with a compatible cannula.
Part 2 - ECoG strip electrodes with a minimum of 4 contacts, and a maximum of 6, ready to be placed on the cerebral cortex during the implantation of DBS electrodes and enabling the registration of the LFP (local field potential) signal.
Part 3 - cables connecting the micro electrode used to record activity during DBS implantation with the FHC guideline 5 recording system and enabling the registration of the LFP (local field potential) signal.
A detailed description of the minimum technical and functional parameters of the subject of the contract is included, respectively for each of the parts, in Annexes No. 2.1 -2.3 to the SWZ - Parameters Form.
The description of the method of performance of the contract is included in the annexes to the SWZ - Draft Agreement.
Purchase and successive delivery to the Institute's headquarters of microelectrodes for microrecording during DBS implantation procedure in a set with a compatible cannulaThe subject of part No. 1 of the order is the purchase and successive delivery to the headquarters of the Institute of microelectrodes for microrecording during the DBS implantation procedure in a set with a compatible cannula.
The Ordering Party shall purchase the subject of the order in the number of pieces of 10 electrodes with cannulas (basic order). Under the right of option, the ordering party may order an additional 70 electrodes with cannulas (right of option). Thus, the scope of the order guaranteed is 10 pcs. electrodes with cannulas - basic order, and in the case of exercising the right of option - a maximum of an additional 70 pcs. electrodes with cannulas, i.e. a total of up to 80 electrodes with cannulas. The contracting authority will exercise the right of option as part of the emergence of scientific and research needs, so the condition for exercising the right of option will be to recruit an appropriate number of patients for the conducted scientific research. The order under the right of option will depend on the number of patients recruited and the number of cannula electrodes necessary to carry out the tests.
The purchase will take place in several tranches after sending a partial order (e.g. 1 tranche - ordering 4 electrodes with cannulas, 2 tranche - ordering 6 electrodes with cannulas, 3 tranche - ordering 6 electrodes with cannulas, etc.) during the term of the contract. The number of pieces in individual tranches will be related to the current needs of the Ordering Party. Each time in a partial order, the Ordering Party shall specify the number of pieces of the subject of the order.
The maximum duration of the contract is 12 months. The contract will be executed until the end of its term or until the pool of 80 electrodes with cannulas is exhausted.
Other requirements:
- sterile preparation of electrodes and cannulas for use in neurosurgical procedures;
- the electrodes and cannulas offered must bear the CE marking for compliance with all relevant requirements in force in the EU, i.e. Regulation 2017/745 on medical devices (formerly Medical Devices Directive 93/42/EEC) applicable to active implantable medical devices (these are medical devices intended to be introduced into the human body and partially introduced into the body by surgery or by medical intervention into the opening; natural and intended to remain in it after the treatment). The Contractor must attach to the Offer a CE Mark safety certificate or equivalent for the electrode offered.
Delivery time requirements:
The Ordering Party requires that the delivery of electrodes each time takes place no later than 30 days after placing a given partial order. Offers offering a longer delivery period than indicated will be rejected. Contractors may propose in their tenders a shorter delivery time for partial contracts. Offering a shorter delivery time is one of the criteria for evaluating offers.
Warranty requirements:
The Ordering Party requires at least a 12-month warranty period for the delivered subject of the contract. Offers offering a shorter warranty period than indicated will be rejected. Contractors may propose a longer warranty period in their tenders. Offering a longer warranty period for the delivered subject of the contract is one of the criteria for evaluating offers.
Detailed description of the parameters of the subject of the contract - a description of the minimum functional and technical requirements expected from the offered subject of the contract, is included in column B of the Table of Annex 2.1 to the SWZ - Parameters.
All conditions and manner of implementation of the subject of the contract are specified in the draft provisions of the contract described in Annex 9.1 to the SWZ - Draft contract.
The offered gross prices included in the offer form (Appendix No. 1 to the SWZ) must include all costs incurred for the purchase of the subject of the contract.
Purchase and successive delivery to the headquarters of the Institute of ECoG strip electrodes with a minimum of 4 contacts, and a maximum of 6, ready to be placed on the cerebral cortex during electro implantationThe subject of the contract lot no. 2 is the purchase and successive delivery to the headquarters of the Institute of ECoG strip electrodes with a minimum of 4 contacts, and a maximum of 6, ready to be placed on the cerebral cortex during the implantation of DBS electrodes and enabling the registration of the LFP (local field potential) signal.
The Ordering Party shall purchase the subject of the order in the number of pieces of 10 electrodes (basic order). Within the framework of the right of option, the ordering party may order an additional 70 electrodes (right of option). Thus, the scope of the order guaranteed is 10 pcs. electrodes - basic order, and in the case of exercising the right of option - a maximum of an additional 70 pcs. electrodes, i.e. a total of up to 80 electrodes. The contracting authority will exercise the right of option as part of the emergence of scientific and research needs, so the condition for exercising the right of option will be to recruit an appropriate number of patients for the conducted scientific research. The order under the right of option will depend on the number of patients recruited and the number of electrodes necessary to carry out the tests.
The purchase will take place in several tranches, after sending a partial order (e.g. 1 tranche - order 4 electrodes, 2 tranche - order 6 electrodes, 3rd tranche - order 6 electrodes, etc.) during the term of the contract. The number of pieces in individual tranches will be related to the current needs of the Ordering Party. Each time in a partial order, the Ordering Party shall specify the number of pieces of the subject of the order.
The maximum duration of the contract is 12 months. The contract will be executed until the end of its term or until the pool of 80 electrodes is exhausted.
Other requirements:
- sterile preparation of electrodes for use in neurosurgical procedures;
- the electrodes offered must bear the CE marking for compliance with all relevant requirements in force in the EU, i.e. Regulation 2017/745 on medical devices (formerly Medical Devices Directive 93/42/EEC) applicable to active implantable medical devices (these are medical devices intended to be introduced into the human body and partially introduced into the body by surgery or through medical intervention into a natural orifice and intended to remain in it after the procedure). The Contractor must attach to the Offer a CE Mark safety certificate or equivalent for the electrode offered
Delivery time requirements:
The Ordering Party requires that the delivery of electrodes each time takes place no later than 30 days after placing a given partial order. Offers offering a longer delivery period than indicated will be rejected. Contractors may propose in their tenders a shorter delivery time for partial contracts. Offering a shorter delivery time is one of the criteria for evaluating offers.
Warranty requirements:
The Ordering Party requires at least a 12-month warranty period for the delivered subject of the contract. Offers offering a shorter warranty period than indicated will be rejected. Contractors may propose a longer warranty period in their tenders. Offering a longer warranty period for the delivered subject of the contract is one of the criteria for evaluating offers.
Detailed description of the parameters of the subject of the contract - a description of the minimum functional and technical requirements expected from the offered subject of the contract, is included in column B of the Table of Annex 2.2 to the SWZ - Parameters.
All conditions and manner of implementation of the subject of the contract are specified in the draft provisions of the contract described in Annex 9.2 to the SWZ - Draft contract.
The offered gross prices included in the offer form (Appendix No. 1 to the SWZ) must include all costs incurred for the purchase of the subject of the contract.
purchase and successive delivery to the Institute's headquarters of cables connecting the micro electrode used to record activity during DBS implantation with the FHC guideline 5 recording systemThe subject of the contract for Lot No. 3 is the purchase and successive delivery to the headquarters of the Institute of cables connecting the micro electrode used to record activity during DBS implantation with the FHC guideline 5 registration system and enabling the registration of the LFP (local field potential) signal.
The Ordering Party shall purchase the subject of the order in the number of pieces of 15 cables (basic order). Under the right of option, the contracting authority may order an additional 85 pieces of cables (right of option). Thus, the scope of the contract guaranteed is 15 pcs. cables - basic order, and in the case of exercising the right of option - a maximum of 85 additional pcs. cables, i.e. a total of up to 100 pieces of cables. The contracting authority will exercise the right of option as part of the emergence of scientific and research needs, so the condition for exercising the right of option will be to recruit an appropriate number of patients for the conducted scientific research. The order under the right of option will depend on the number of patients recruited and the number of cables necessary to carry out the research.
The purchase will take place in several tranches after sending a partial order (e.g. 1 tranche - order 10 cables, 2 tranche - order 5 cables, 3rd tranche - order 5 cables, etc.) during the term of the contract. The number of pieces in individual tranches will be related to the current needs of the Ordering Party. Each time in a partial order, the Ordering Party shall specify the number of pieces of the subject of the order.
The maximum duration of the contract is 12 months. The contract will be executed until the end of its term or until the pool of 100 cables is exhausted.
Other requirements:
- sterile preparation of the cable for use in neurosurgical procedures
Delivery time requirements:
The Ordering Party requires that the delivery of electrodes each time takes place no later than 30 days after placing a given partial order. Offers offering a longer delivery period than indicated will be rejected. Contractors may propose in their tenders a shorter delivery time for partial contracts. Offering a shorter delivery time is one of the criteria for evaluating offers.
Warranty requirements:
The Ordering Party requires at least a 12-month warranty period for the delivered subject of the contract. Offers offering a shorter warranty period than indicated will be rejected. Contractors may propose a longer warranty period in their tenders. Offering a longer warranty period for the delivered subject of the contract is one of the criteria for evaluating offers.
Detailed description of the parameters of the subject of the contract - a description of the minimum functional and technical requirements expected from the offered subject of the contract, is included in column B of the Table of Annex 2.3 to the SWZ - Parameters.
All conditions and manner of implementation of the subject of the contract are specified in the draft provisions of the contract described in Annex 9.3 to the SWZ - Draft contract.
The offered gross prices included in the offer form (Appendix No. 1 to the SWZ) must include all costs incurred for the purchase of the subject of the contract.