The subject of the order is the delivery, installation and service of a heat sink for irradiation of blood and its components for the needs of the Regional Centre for Blood and Hematopoiesis in Kalisz
1. New device - date of production not earlier than 2021, in accordance with the technical specification supplied to tender
2. Device manufactured in accordance with European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices - CE mark.
3. The device must meet electrical safety standards according to EU standards.
4. The device should be made of materials for easy cleaning and disinfection.
5. Monitoring system, power supply with surge protection and automatic voltage regulator.
6. The device provides software in Polish,
7. Device having instructions for operation, operation and maintenance in Polish.
8. A device that is a replacement for isotopic heatsinks, allowing to irradiate blood components without using isotopic sources.
9. Device for irradiation of blood and its components using X-rays.
10. Device safe for the operator/user of the device, not emitting harmful radiation in the environment, with negligible external impact. Radiation emitted outside devices not exceeding 1 µSv/h. A device not requiring surveillance of the State Atomistics Agency (PAA).
11. The device together with the necessary apparatus (monitor, computer, printer, barcode scanner, label printer, etc.) and software and the ability to transfer data to the “BLOOD BANK” IT system for which the Ordering Party has the relevant licenses. The costs associated with the connection to the system “BLOOD BANK” shall be borne by the Contractor. Device control software in Polish.
12. The device is intended to receive NUKKCz/NUKKP blood components without causing significant blood cell damage and preventing TA-GvHD (post-tranfusion disease against recipient).
13. A device allowing continuous monitoring of the irradiation process and temperature in the irradiation chamber.
14. A device that allows to control the irradiation process by visual evaluation of radiative labels designed to irradiate blood and its components change the color/appearance under the influence of X-radiation.
15. The device has protection against twice irradiation of the same container by cross-checking with a database of exposed products.
16. Device providing a uniform distribution of the radiation dose to the blood preparation and its components, emitting a dose of radiation ranging from 25Gy to 50 Gy according to the current Health Minister's Approvement on the requirements of good practice for the collection of blood and its components, research, preparations, storage, dispensing and transport for organizational units of the public blood service. (point 7.1.13)
17. A device that allows the irradiation of more than one preparation of blood or its components and irradiation of various blood components at one time.
18. A device that allows operation at 18°C-25°C and does not emit additional heat into the room.
19. The device must be equipped with an internal shielding system that does not require external security or a specially adapted room
20. The device covered by 24 months warranty, the warranty also includes work and access of staff at the contractor's expense.
21. Device warranty card containing a detailed description of the warranty and the resulting user privileges
22. The Contractor undertakes to start the removal of heatsink failures within 48 hours from the time of the notification of the failure and to remove the failure within 14 working days (the date of repair of the device is a criterion for selecting the offer see paragraph. XIX SWZ criteria for selecting the offer and their description).
23. Dose measurement for the component and control of radiation emission outside the device min. Twice a year.
24. The Contractor shall be responsible for the installation and technical qualification of the device.