1. The object of the order is:
1) lease of fully automated primary analyzer and back-up analyzer for immunohematological testing of donors and blood recipients working in microcolumn technology together with a software license to manage test results and required instrumentation and program antivirus, as well as hooking up to the Ordering Party's IT system. Currently, the IT system is provided by Asseco Poland SA;
2) lease of devices for manual micromethod i.e. 4 centrifuges for microcards, 2 incubators, 5 volume-adjustable automatic pipettes;
3) successive supply of reagents, reference blood cells and all consumable materials, including systemic fluids used in immunohematological tests for manual and automatic micromethod.
1. The object of the order is:
1) lease of fully automated primary analyzer and back-up analyzer for immunohematological testing of donors and blood recipients working in microcolumn technology together with a software license to manage test results and required instrumentation and program antivirus, as well as hooking up to the Ordering Party's IT system. Currently, the IT system is provided by Asseco Poland SA;
2) lease of devices for manual micromethod i.e. 4 centrifuges for microcards, 2 incubators, 5 volume-adjustable automatic pipettes;
3) successive supply of reagents, reference blood cells and all consumable materials, including systemic fluids used in immunohematological tests for manual and automatic micromethod.
2. In order to confirm that the deliveries offered meet the requirements, characteristics, criteria specified by the Ordering Party, the Contractor shall submit together with the offer:
(a) for reagents, standard blood cells, solutions which are medical devices as well as analyzers, centrifuges and incubators which are medical devices (does not apply to automatic pipettes including terminals thereto)
- Application of the device to the President of the Office for Registration of Medicinal Products and Biocidal Products (hereinafter referred to as the President of URPLWMiPB) or notifying the President of URPLWMiPB of the introduction of the device into the territory of the Republic of Poland in accordance with Article 58 of the Act of 20 May 2010 on medical devices. Where the Contractor is not subject to the obligation to make a notification/notification (referred to in the previous task), the Contractor's statement containing the grounds for the absence of that obligation;
- Current Certificate of the notified body, with the participation of which the procedure for assessing the conformity of the offered medical devices was carried out — if the medical device offered is listed in Article 29] paragraph 5 of the Act of 20 May 2010 on medical devices (Journal of Laws of 2020 item 186 as late. zm) . ;
- Declaration of conformity by the manufacturer or authorised representative on compliance with essential requirements by the medical devices offered.
(b) For analyzers, centrifuges and incubator:
- technical specifications of equipment and/or device cards and/or equipment catalogue cards confirming that the parameters specified in the description of the subject of the order are met.
Attention:
If the executor does not submit the means of evidence in question or the evidence submitted in question are incomplete, the Contracting Authority shall, in accordance with Article 107 (2) of the Pzp Act, call upon the executor to submit them or supplement them within the deadline set.