DELIVERY OF SENSORS FOR PULSE OXIMETERS FOR NEWBORNS TOGETHER WITH PULSE OXIMETER LEASE

1. The subject of the order is the delivery of sensors for pulse oximeters for newborns to the Ordering Party's premises (Kraków, os. Złotej Jesieni 1) along with the lease of pulse oximeters, in accordance with the description and requirements contained in Annex No. 1A and 1B to these specifications. 2. Requirements for sensors for pulse oximeters for newborns (detailed description in Annex 1A to these specifications): • The expiry date / warranty period of the subject of the order cannot be shorter than 12 months from the date of delivery. • The Contractor undertakes to conduct training for the Ordering Party's personnel at their premises – os. Złotej Jesieni 1, Kraków, at the request of the Ordering Party, along with the first delivery of goods to the Hospital Pharmacy within a period agreed in writing with the Ordering Party, but no later than 30 days from the date of concluding the contract. • The Contractor will be obliged to submit a list of attendees from the conducted training, with the signatures of the trained users confirming their actual attendance to the Hospital Pharmacy, within 5 working days from the date of conducting the training. • The Ordering Party reserves the right to ask Contractors at the stage of examining and evaluating offers to provide samples of the offered subject of the order for testing and verification. Costs related to this are borne by the Contractor. • Offers that do not cover the full scope of the subject of the order will be rejected. 3. Requirements for the lease of pulse oximeters (detailed description in Annex 1B to these specifications) • Limit parameters for pulse oximeters are described in Annex No. 1B to these SWZ. • The Contractor is obliged on the day of delivery of the subject of the contract to train technical personnel on the delivered devices at the Ordering Party's premises (Kraków, os. Złotej Jesieni 1) or to ensure such training at their own expense by a third party, which will be confirmed by issuing personalized certificates. 4. Other terms of the order are specified in the draft contract, which is Annex No. 3A and Annex No. 3B to the SWZ. EVIDENCE ITEMS 1. The Ordering Party requires the submission with the offer:  for sensors for pulse oximeters for newborns: a) detailed description of the subject of the order (information leaflet, current catalog with a detailed description or technical data sheet upon request of the Ordering Party) documents must confirm the requirements described in Annex No. 1A of the SWZ); the catalog number of the offered product must be provided, b) documents proving market authorization, i.e. respectively: 1) manufacturer's declaration of conformity, 2) CE certificate (if applicable), 3) notification or announcement to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and in case of product registration under Art. 138 sec. 7 of the Act of April 7, 2022 on Medical Devices, confirmation of product registration in the EUDAMED database with a unique registration number issued by URPL, 4) for products not subject to the provisions of the Act of April 7, 2022 on Medical Devices, the Contractor is obliged to provide documents other than those mentioned above, appropriate for authorizing these products for circulation and use, c) statement / documents from the equipment manufacturer confirming the compatibility of the subject of the order with the Ordering Party's equipment indicated in Annex 1A to the SWZ  for pulse oximeters a) CE Certificate or Declaration of Conformity 2. In accordance with Art. 107 sec. 2 of the Pzp Act, the Ordering Party informs that if the contractor fails to submit the evidence items or if the submitted evidence items are incomplete, the ordering party will request their submission or supplementation within the specified period. 3. The Ordering Party also accepts certificates issued by other equivalent conformity assessment bodies. 4. The Ordering Party accepts appropriate evidence items, other than those referred to in Art. 105 sec. 1 and 3 of the Pzp Act, in particular the manufacturer's technical documentation, in the case of g...