Poland - Medical devices

Description

The subject matter of the contract was divided into 3 parts. Task no. 1: Defibrillator - Defibrillator with the possibility of stimulation and full monitoring; equipped with hard and disposable buckets and dual power system (mains and battery), described in Appendix no. 2a to the ToR. Within each task the Economic Operator will be obliged to 1) delivery of equipment to the Ordering Party's seat, meeting the requirements specified in the List of technical and operational parameters of the subject matter of the order, constituting Appendix 2a-2c to the ToR; 2) installation and installation of equipment; 3) configuration and commissioning of equipment; 4) checking the correctness of equipment operation; 5) handing over to the Ordering Party for use of efficient equipment ready for use; the Economic Operator shall submit statements and documents in electronic form, bearing a qualified electronic signature, valid as of the day of submitting tenders. Declaration in the form of a Single European Procurement Document, hereinafter referred to as 'ONE', to the extent indicated by the contracting authority in the contract notice or in the Specification of Essential Terms of Contract, drawn up in accordance with the standard form set out in the European Commission Implementing Regulation issued pursuant to Article 59(2) of Directive 2014/24/EU and Article 80(3) of Directive 2014/25/EU. The information contained in the statement will constitute a preliminary confirmation that the contractor is not subject to exclusion and meets the conditions for participation in the procedure. The ONE form should be submitted in electronic form with a qualified electronic signature. The ONE form in an electronic version and the instructions for filling it in are available at https://www.uzp.gov.pl. 9) In order to confirm that the deliveries offered meet all the requirements set by the Awarding Entity in the ToR, the Economic Operator shall present: a) in accordance with the Act on Medical Devices of 20.5.2010. (Journal of Laws of 2019.175) - valid and up-to-date as of the date of submission of documents confirming the admission to trading in the territory of the Republic of Poland: a.1) CE declaration of conformity confirming compliance with Directive 93/42/EEC, a.2) entry or notification/notification to the Register of Medical Devices, a.3) certificate of conformity issued by a notified body, a.4) other documents - in accordance with the applicable laws Each document should be described, which item from the annex - respectively - No. 2a-2c to the ToR. b) technical data sheets of the equipment manufacturer or catalogues, containing data identifying the equipment offered (e.g. own names, catalogue numbers), or in the absence of catalogues, brochures or source materials of the manufacturer, which in a clear and legible manner confirm compliance with technical parameters described by the Ordering Party in Annex - respectively - No. 2a-2c to the ToR. In the case of the user manual, the title page and the page with the declared parameter should be presented. Failure to confirm the required parameters will be considered as non-fulfilment of such parameters by the offered equipment and will result in rejection of the offer, unless the conditions specified in Article 26(3) of the PPL Act are met. If the above documents are drawn up in a foreign language, the document(s) must be submitted together with a translation into Polish. The subject matter of the contract was divided into 3 parts. The offer may be submitted for the whole order or for individual parts/tasks: task no. 2: Cardio-monitor + Central monitoring station - Cardio-monitor enabling recording of ECG, HR, saturation, respiratory rate, non-invasive blood pressure measurement, body temperature, equipped with software enabling data transmission and computer archiving, described in attachment no. 2b to the ToR. Within the framework of each task, the Contractor shall be obliged to 1) delivery of equipment to the Ordering Party's seat, meeting the requirements specified in the List of technical and operational parameters of the subject matter of the order, constituting Appendix 2a-2c to the ToR; 2) installation and installation of equipment; 3) configuration and commissioning of equipment; 4) checking the correctness of equipment operation; 5) providing the Ordering Party with efficient equipment ready for use for operation; 6) providing the Ordering Party with standby instruction on the use of the supplied equipment for the Ordering Party's personnel; 7) providing ongoing warranty service - on the terms specified in the draft agreement, constituting Appendix 4 to the ToR.Bidders should submit statements and documents in electronic form, with a qualified electronic signature, valid as of the date of submission of tenders. Declaration in the form of a Single European Procurement Document, hereinafter referred to as 'ONE', to the extent indicated by the contracting authority in the contract notice or in the Specification of Essential Terms of Contract, drawn up in accordance with the standard form set out in the European Commission Implementing Regulation issued pursuant to Article 59(2) of Directive 2014/24/EU and Article 80(3) of Directive 2014/25/EU. The information contained in the statement will constitute a preliminary confirmation that the contractor is not subject to exclusion and meets the conditions for participation in the procedure. The ONE form should be submitted in electronic form with a qualified electronic signature. The ONE form in an electronic version and the instructions for filling it in are available at https://www.uzp.gov.pl. 9) In order to confirm that the deliveries offered meet all the requirements set by the Awarding Entity in the ToR, the Economic Operator shall present: a) in accordance with the Act on Medical Devices of 20.5.2010. (Journal of Laws of 2019.175) - valid and up-to-date as at the date of submission of documents confirming the admission to trading in the territory of the Republic of Poland: a.1) CE declaration of conformity confirming compliance with Directive 93/42/EEC, a.2) entry or notification to the Register of Medical Devices, a.3) certificate of conformity issued by a notified body, a.4) other documents - in accordance with the applicable provisions of law. Each document should describe which item from Annex - respectively - No. 2a-2c to the ToR applies.b) technical data sheets of the equipment manufacturer or catalogues, containing data identifying the equipment offered (e.g. own names, catalogue numbers), and in the absence of catalogues, brochures or source materials of the manufacturer, which clearly and clearly confirm compliance with technical parameters described by the Ordering Party in the Annex - No. 2a-2c to the ToR respectively.In the case of user manuals, the cover page and page with the declared parameter should be presented. Failure to confirm the required parameters will be considered as non-fulfilment of such parameters by the offered equipment and will result in rejection of the offer, unless the conditions specified in Article 26(3) of the PPL Act are met. If the above documents are drawn up in a foreign language, the document(s) must be submitted together with a translation into Polish. The subject matter of the contract was divided into 3 parts. The offer can be placed for the whole order or for individual parts/tasks: task no. 3: ECG device - 12-channel ECG device with software and the possibility to export data to an IT network, ECG Holter set - ECG analysis system by Holter method with software for parameter analysis and five recorders + RR hole set - RR measurement system by Holter method with software and five recorders, described in Appendix no. 2c to the ToR. Within the framework of each task, the Contractor shall be obliged to 1) delivery of equipment to the Ordering Party's seat, meeting the requirements specified in the List of technical and operational parameters of the subject matter of the order, constituting attachment No. 2a-2c to the ToR; 2) installation and installation of equipment; 3) configuration and commissioning of equipment; 4) checking the correctness of equipment operation; 5) handing over to the Ordering Party efficient equipment ready to use for operation; 6) providing the Ordering Party with a station instruction on the use of the supplied equipment for the Economic Operator to the bid should submit statements and documents in electronic form, with a qualified electronic signature, valid as of the day of submitting the bid. Declaration in the form of a Single European Procurement Document, hereinafter referred to as 'ONE', to the extent indicated by the contracting authority in the contract notice or in the Specification of Essential Terms of Contract, drawn up in accordance with the standard form set out in the European Commission Implementing Regulation issued pursuant to Article 59(2) of Directive 2014/24/EU and Article 80(3) of Directive 2014/25/EU. The information contained in the statement will constitute a preliminary confirmation that the contractor is not subject to exclusion and meets the conditions for participation in the procedure. The ONE form should be submitted in electronic form with a qualified electronic signature. The ONE form in an electronic version and the instructions for filling it in are available at https://www.uzp.gov.pl. 9) In order to confirm that the deliveries offered meet all the requirements set by the Awarding Entity in the ToR, the Economic Operator shall present: a) in accordance with the Act on Medical Devices of 20.5.2010. (Journal of Laws of 2019.175) - valid and up-to-date as at the date of submission of documents confirming the admission to trading in the territory of the Republic of Poland: a.1) CE declaration of conformity confirming compliance with Directive 93/42/EEC, a.2) entry or notification to the Register of Medical Devices, a.3) certificate of conformity issued by a notified body, a.4) other documents - in accordance with the applicable provisions of law. Each document should describe which item from Annex - respectively - No. 2a-2c to the ToR applies. b) technical data sheets of the equipment manufacturer or catalogues, containing data identifying the equipment offered (e.g. own names, catalogue numbers), and in the absence of catalogues, brochures or source materials of the manufacturer, which in a legible and clear manner confirm compliance with technical parameters described by the Ordering Party in Annex - No. 2a-2c to the ToR. in the case of manuals, the title page and page with the declared parameter should be presented. Failure to confirm the required parameters will be considered as non-fulfilment of such parameters by the offered equipment and will result in rejection of the offer, unless the conditions specified in Article 26(3) of the PPL Act are met. If the above documents are drawn up in a foreign language, the document(s) must be submitted together with a translation into Polish.

Opportunity closing date

23 May 2019

Value of contract

to be confirmed