Poland – Electrodes – Dostawa elektrod do ablacji i koagulacji wewnątrzstawowej kompatybilnych z posiadanym generatorem RF dla potrzeb bloku operacyjnego przez okres 24 miesięcy

The subject of the contract is the successive delivery of ablation and intra-articular coagulation electrodes compatible with the owned RF generator for the needs of the operating block for a period of 24 months.

The contract includes the supply of ablation and intra-articular coagulation electrodes, compatible with the owned arthroscopic energy generator AES-1 by Conmed.

All offered accessories should be a medical device.

The offered elements should be for direct use – sterile.

All offered accessories should be marked with the CE conformity mark.

The detailed description of the subject of the contract includes the price list, which is Annex 1A to the SWZ.

The contractor is obliged to implement the contract on the principles and conditions described in the contract template, which is Annex 3 to the SWZ.

The Purchaser, in order to confirm the conformity of the offered supplies, requires the submission of the following documentary evidence with the offer:

1) Declaration of Conformity – a document issued by the manufacturer of the product or its authorized representative. (applies to all classes of medical devices)

2) Certificate of Conformity – a document issued by a notified body in the field of medical devices, confirming the completion of conformity assessment procedures. (applies to medical devices classified as: Class I sterile, Class I with measuring function, Class IIa, IIb, III and in accordance with EU Directive 98/79, Class A and B devices)

3) Catalog cards of the offered electrodes together with drawings and catalog numbers

Documentary evidence prepared in a foreign language should be submitted together with a translation into Polish.

The Purchaser requires that the documentary evidence be prepared in electronic form and signed with a qualified signature by the Contractor.

In the event that the documentary evidence has been prepared in electronic form and signed with a qualified signature by its issuer (authorized entity), it should be submitted in that form.

In the case where the documentary evidence has been issued in paper form, a digital copy of the document signed with a qualified signature by the contractor should be submitted.

In the event that the Contractor does not submit the documentary evidence with the offer or the submitted documentary evidence is incomplete, the Purchaser will request their submission or completion within a specified deadline.

The Purchaser requires that the documentary evidence confirm the actual status as of the date of submission of the offers.

The Purchaser requires that the documentary evidence be up-to-date as of the date of submission/completion.

1) Declaration of non-exclusion from the procedure, prepared in the form of the European Single Procurement Document (ESPD) - according to the template which is Annex 2 to the SWZ. The Purchaser informs that the Contractor, when completing the declaration on the ESPD form, may also use the tool available at: https://espd.uzp.gov.pl/

a) The declaration constitutes a preliminary confirmation that the contractor is not subject to exclusion as of the date of submission of the offers.

b) The declaration is submitted by each of the contractors jointly applying for the award of the contract. The declaration must demonstrate the absence of grounds for exclusion of each of the contractors.

2) The Purchaser informs that the Contractor may use the document (ESPD) submitted in a separate procurement procedure, if it confirms that the information contained therein remains correct.

3) Declaration that the contractor is not subject to exclusion under Article 7(1) of the Sanctions Act and Article 5k of the EU Regulation – the content of the declaration is included in the offer form, which is Annex 1 to the SWZ

XII DESCRIPTION OF THE METHOD OF PREPARING THE OFFER

1. The Contractor is obliged to submit on the date of submission of the offers:

a) Offer form using the template which is Annex 1 to the SWZ

b) Price list using the template which is Annex 1A to the SWZ

c) Contractor's Declaration (ESPD) - according to the template which is Annex 2 to the SWZ

d) Declaration of non-exclusion in the scope of the Sanctions Act – the content of the declaration is included in the offer form

e) Documentary evidence, as mentioned in Section VIII of the SWZ

f) Power of Attorney (if applicable)

NOTE!!! Annexes 1 and 1A to the SWZ constitute the content of the offer and, consequently, are not subject to supplementation. The lack of these documents constitutes the invalidity of the submitted offer.