Contract for the supply, installation, commissioning and personal training of medical equipment for the endowment of the Cardiology Department / 3 lots: LOT 1 = SOUND CALLING SYSTEM x 1 pcs. LOT 2 = HIGH PERFORMANCE ECOGRAPH x 2 pcs. LOT 3 = PATIENT MONITORING CENTRAL STATION x 1 pcs Delivery and commissioning will be done with authorized personnel and are operations included in the price. A statement to that effect will be attached. The installation and commissioning of medical equipment involves several stages, from the preparation of the space and the verification of the documentation, to the actual installation, testing and training of the personnel. It is a complex process to be carried out by competent technical staff. Mandatory minimum main steps: 1. Preparation of the installation site: Before starting the installation, it must be ensured that the installation site is properly prepared. This includes finishing preparatory work, checking electrical, sanitary and other utilities necessary for the operation of the appliance. 2. Documentation check: Competent technical personnel shall verify the documentation of the appliance, including the user manual, technical specifications and other relevant documentation, to ensure that all installation requirements are met. 3. Installation itself: The appliance shall be installed as specified in the documentation. This stage may involve mounting components, connecting to utility networks and fixing the appliance in the intended place. 4. Testing and commissioning: After installation, the device is tested to check its correct functionality. Various tests and checks are carried out to ensure that the operating parameters are within the specified limits. If everything works properly, the machine is put into operation. 5. Staff training: Healthcare professionals who will use the appliance must be trained on its correct and safe use. The training may include practical demonstrations, explanation of the functions and characteristics of the appliance, and safety procedures. The training of the operator and medical personnel is carried out at the beneficiary, at the delivery location and is an operation included in the price. A statement to that effect will be attached. 6. Maintenance and service: After commissioning, it is important to ensure regular maintenance of the appliance as instructed by the manufacturer. There must also be a service available for any malfunctions or repairs. Ensuring the implementation of proper preventive maintenance, both on the part of the user and the supplier, ensuring with the right consumables and spare parts, early resolution of emerging problems are the basis for the durability of medical devices. 7. Notification of NAMMD: For certain activities of marketing, repair, maintenance and commissioning/installation of medical devices, notification to the Romanian National Agency for Medicines and Medical Devices (ANMDMR) is required. Ancillary operations related to the supply of equipment include: • Delivery and commissioning of equipment by authorized personnel, operations included in the tendered price; a declaration of conformity shall be attached to this effect; • Training of the operating and medical staff at the premises of the beneficiary as an integral part of the delivery of the equipment. The training will include not only the correct and safe use of equipment, but also the application of sustainable practices such as: SEE TABLE OF TASKS
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