The subject of the contract is a radiator for irradiation of blood and its components using X-ray X-rays together with software, all equipment necessary for the proper functioning of the device – a detailed description of the subject of the contract is included in Annex 1 to the SWZ.

The subject of the contract is a heat sink for irradiation of blood and its components using X-rays X together with software, all equipment necessary for the proper functioning of the device. The ordering party requires a minimum 36-month warranty on the device and removal of the device failure in a maximum of 7 days.

The order should be completed within 4 months from the date of signing the contract.

To confirm that the offered products meet the requirements of the Ordering Party, subject documents should be submitted, i.e. current ones:

a) for devices subject to the obligation to notify/notify/transfer data on a medical device to the database of the President of the Office for Registration of Medicinal Products for Medical Devices and Biocidal Products pursuant to the Act of 20 May 2010 on medical devices (i.e. Journal of Laws of 2021, item 1565), a statement of the Contractor is required that the offered devices (listed in the statement) are in the database of the President of the Office for Registration of Medicinal Products for Medical Devices and Biocidal Products (model declaration in Annex 6).

(b) EU declaration(s) of conformity confirming CE marking.

c) Technical specifications of the offered products confirming compliance with the requirements contained in Annex 1 to the SWZ - if the above-mentioned documents indicate the products/functionalities available optionally, the Contracting Authority requires a clear indication of which of the options constitutes the Contractor's offer.

If the Contractor does not submit the evidence referred to above in points a) to c) or the evidence submitted is incomplete, the Contracting Authority, in accordance with Article 107 paragraph 2 of the Act, shall call for their submission or supplementation within the prescribed period.