1. The subject of the contract is: supply of surgical instruments for the operation of the Prof. A. Gruca SPSK CMKP operating unit in Otwock. 2. The order includes the delivery of tool kits with the adopted names: Task 1 Hip Task 2 Knee Task 3 Foot Task 4 Small Task5 Teaming Task 6 Nail Task 7 Children Task 8 Spoons Task 9 Knife chisels Task 10 Hooks Task 11 Mammals Task 12 Kerrisony Task 13 Baskets and containers Task 14 Reverse and automatic Hooks Task 15 Spine OT Task 16 Additional tools The customer does not allow partial tenders for selected tasks for technical and organizational reasons related to service and supervision over the operation of tools at the customer's premises. The subject of the contract are one type of manual surgical tools, grouped into the tool kits necessary to perform operational procedures (individual tasks). 3. General scope of tasks related to the supply of tools: 1) Sales 2) Labelling of tools with hospital inventory numbers 3) Delivery 4) Submission of documents required for collection: notification by the contractor of the fact of readiness to receive, required attestations of certificates and instructions 4. The Ordering Party requires that all offered tools, containers and baskets constitute a medical device and are admitted to trading in accordance with the Act of 7 April 2022 on medical devices. Contract implemented on the basis of an agreement to entrust the implementation of tasks from the Victim Support Fund and Post-Penitentiary Assistance - Justice Fund (task no. 6,8,9,10,11,12,13,15,16) 1. In order to confirm the conformity of the supplies offered, the Contracting Authority requests that the following means of proof be submitted with the tender: 1) Declaration of Conformity - a document issued by the manufacturer of the device or his authorised representative. (for all classes of medical devices) 2) Certificate of conformity – a document issued by a notified body for medical devices certifying that conformity assessment procedures have been carried out. (applies to medical devices classified in classes: I sterylna, I z funkcją pomiarową, II A, IIb, III oraz zgodnie z dyrektywą unijną 98/79 wyroby klas A i B) 3) Karty katalogowe i/lub katalogi zaoferowanych narzędzi zawierające kod narzędzia i lub/numer katalogowy, rysunek lub fotografię narzędzia oraz wymiary potwierdzające wymagane parametry -dotyczy zadań nr od 1 do nr 12 i od nr 14 do nr 16 4) Karty katalogowe i/lub katalogi i/lub inne materiały źródłowe producenta (np. foldery, prospekty, dane techniczne, instrukcje lub fragmenty instrukcji obsługi oferowanego produktu i fragmenty instrukcji serwisowych, zdjęcia z opisem) potwierdzające wymagane parametry graniczne zaoferowanego asortymentu. The documents should contain, in addition to the description of the parameters - the full name of the product and the catalog number. The Ordering Party accepts the statement of the manufacturer of the assortment as a document confirming the required technical parameters. The Contracting Authority does not allow a declaration by a contractor authorised by the manufacturer to service and sell the offered assortment and documents drawn up by the contractor authorised by the manufacturer to service and sell the offered assortment in order to confirm the technical parameters, as well as a declaration by the distributors of the assortment - concerns task No. 13 2. The Contracting Authority shall require that the means of proof in question be drawn up in electronic form and bear a signature qualified by the Contractor. 3. Where the means of proof in question have been drawn up in electronic form and bear a qualified signature by their issuer (authorised entity), they must be provided in that form. 4. Where the means of proof in question are issued on paper, a digital reproduction of the document with a qualified signature by the contractor must be provided. 5. If the Contractor fails to submit the means of proof in question with his tender or the means of proof in question are incomplete, the Contracting Authority shall call for them to be submitted or completed within the prescribed time limit.
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