1) Development of medical devices of an outpatient specialist care institution affecting the entire population of Mezőkövesd District within the framework of the Competitive Walks Programme. 2) The contracting authority's procurement needs within the framework of the development project include the following tools and products: 1. Tender part: Acquisition of dental equipment -Acquisition of digital dental panorama x-ray equipment 1 pcs -Acquisition of dental wall-arm x-ray equipment 1 pcs 2. Tender part: Purchase of imaging equipment -Full body X-ray equipment 1pc -High-definition detection workstation 1pc 3. Tender part: Acquisition of ophthalmic instruments -Visual field testing equipment 1 pc -Ophthalmic diagnostic lenses 1 pc 4. Tender part: Purchase of low value equipment -Heat air sterilization equipment 1 pc -Water distillation equipment 1 pc -Line code printer 1 pc -Electrocauter equipment 1 pc 5. Ultrasound - Ultrasound device 1 pc 3) Instead of the standard, technical authorisation, technical specifications, technical recommendation or type set out in the Call for Tenders and the technical documentation, the contracting authority accepts a technically, functionally and quality-equivalent recommendation, the name of the make or type in the Call for Tenders and Documentation was used to clearly define the nature of the subject matter. Any indication of type or make shall be understood to mean ‘or equivalent’. Equivalence shall be demonstrated and supported by appropriate documents in the tender submitted by the tenderer. (321/2015. Section 46(3) and (5) of Government Decree No 487/2015). As regards the exact specification of product characteristics, the contracting authority draws attention to Decision No D.225/9/2009 of the Public Procurement Arbitration Board. 4) Further information on the products to be procured can be found in the technical specification tables that are part of the Public Procurement Documentation. 5) Other requirements for all lots: 5.1. The winning bidder is responsible for the delivery, installation, commissioning and/or installation of the products offered for all parts. Training of management personnel as follows: Part 1 (both products): 4 people for the period of time specified by the manufacturer of the product. Training is required in Hungarian as part of face-to-face training. Part 2: full body X-ray equipment for 4 persons/detection workstation for 4 persons for the duration specified by the manufacturer of the product. Training is required in Hungarian as part of face-to-face training. Part 3: for 1 person in the case of field of vision test equipment only, for the period of time specified by the manufacturer of the product. Training is required in Hungarian as part of face-to-face training. Part 4: 2 people for hot air sterilisation equipment / 4 people for water distillation equipment / 3 people for barcode printing equipment / 3 people for surgical cutting equipment, for the duration specified by the product manufacturer. Training is required in Hungarian as part of face-to-face training. Part 5: ultrasound equipment for 1 person for the duration specified by the manufacturer of the product. Training is required in Hungarian as part of face-to-face training. 5.2. Products offered must be covered by a valid manufacturer's EC declaration of conformity at the time of submission of the tender and, in the case of products classified in a higher risk class: CE conformity assessment certificate stating that the product complies with Decree No 4/2009 of 17 March 2009 of the Minister for Health on medical technology devices and Decree No 8/2003 of the Minister for Health. (III. 13.) ESzCsM and Directives 93/42/EEC and 98/79/EC concerning medical devices, taking into account Regulation (EU) 2017/745 of the European Parliament and of the Council. Documents must be attached by the tenderer as part of the tender. 5.3. In its tender, the tenderer shall attach the completed price table, dated and duly signed. The completed price table must be submitted as part of the offer, both in .pdf and editable (.xls) format! In case of content discrepancies, the pdf document shall prevail. 5.4. In order to make the tenders comparable, the contracting authority drew up a specification table in word format. The technical offer must be provided by filling in this specification table. The table shall specify, in addition to the product characteristics, the name, manufacturer and place of origin of the device proposed and shall indicate the specific type of product. The fact that a product is manufactured individually should also be recorded in the specification table. 5.5. If the Tenderer is not the manufacturer of the product offered, the substantiation of the recommendations set out in the specification table must be confirmed by a product specification/product data sheet signed by the manufacturer of the product in question or the distributor of the product. If the product specification or product data sheet does not contain a product property to be tested according to the specification table, or if there is an inconsistency between the product property recorded in the specification table and the data sheet, the product property shall be verified by a company declaration from the manufacturer or the distributor of the product. The contracting authority draws attention to the fact that, in the case of a product specification/product data sheet or declaration issued/signed by a distributor, the certificate/declaration from the manufacturer of the product, valid at the time of the submission of the tender, supporting the marketing authorisation, must be attached. 5.6. Tenderers must provide a declaration that all certificates/equivalent documents/manufacturer’s declaration of conformity submitted by them are valid at the time of submission of the tender. (ECR Form)
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