Poland – Medical equipments – Dostawa aparatury medycznej, sprzętu medycznego oraz wyposażenia dla Oddziału Anestezjologii i Intensywnej Terapii

The subject of the contract is the supply of medical equipment, medical devices and equipment for the Department of Anesthesiology and Intensive Care, as part of the investment task "Reconstruction of the first floor of building "O" of the Silesian Centre of Oncology to create the Department of Anesthesiology and Intensive Care – II stage of construction and installation works, including obtaining a permit for use". The subject of the contract has been divided into 6 parts/Packages, each of which constitutes a separate subject of the contract. 2. A detailed description of the subject of the contract is in Annex 1a to the SWZ. 3. The subject and conditions for the implementation of this contract must be in accordance with the Act of 7 April 2022 on medical devices and the Regulation of the European Parliament and of the Council (EU) 2017/745 of 5 April 2017 on medical devices or the Regulation of the European Parliament and of the Council (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices (where applicable) and with other applicable legal provisions in this area. The offered devices must have a CE declaration of conformity. This applies to: Package 1 item 1; Package 2; Package 3 items 1, 5, 7; Package 4 item 1; Package 5; Package 6. 4. The devices must be approved for sale and use in the units of the healthcare service in the Republic of Poland, in accordance with the applicable legal provisions (declaration of conformity for the entire device, CE marking, notification or registration of the medical device with the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products). This applies to: Package 1 item 1; Package 2; Package 3 items 1, 7; Package 4 item 1; Package 5; Package 6. 5. The subject of the contract must be complete, ready for use after unpacking, installation, and commissioning without any additional purchases and investments. 6. The offered subject of the contract must be factory new, unused, and not exhibited at exhibitions or trade fairs, not being the subject of scientific research, development work, research services, not being a demonstration or refurbished item, not previously used for any purpose by another entity, technically functional, safe, complete, and ready for work, and must also meet the technical-functional requirements specified in the description of the subject of the contract. 7. The contracting authority does not envisage the possibility of placing orders, as referred to in Article 214(1)(8) of the Pzp Act. 8. As part of the implementation of the subject of the contract, the Contractor will be obliged to conduct the necessary training of the Contracting Authority's personnel in the use of the offered equipment at the Contracting Authority's premises – in accordance with the details of the OPZ. For simple trolleys, stands and equipment, delivery in a state ready for use, without separate installation, is required. The Contracting Authority understands installation – depending on the type of device – as setting up/mounting, connecting to the required media or network, configuring, performing functional tests and handing over the device ready for work. 9. The Contractor will provide a warranty for defects and a quality guarantee for the subject of the contract for a period of at least 24 months and a maximum of 60 months (the warranty period is a criterion for evaluating offers). This does not apply to single-use products. 10. Package 4 item 1 - the offered subject of the contract must meet the requirements of the PN-EN ISO 15883-1 and PN-EN ISO 15883-3 standards or equivalent. 11. Package 1 item 1 - the offered subject of the contract must meet the appropriate safety requirements for patient warming systems, with reference to EN/IEC 80601-2-35 or an equivalent standard.