DIGITAL MAMMOGRAPHY SYSTEM 2D

DIGITAL MAMMOGRAPHY SYSTEM 2D Minimum Product Characteristics No. Specification Item 1 Bucky 1.1 Motorized vertical displacement range ≥ 55 cm to ensure easy patient access in sitting, lying, and standing positions. 1.2 Two touchscreen control panel monitors for adjusting position and compression, one on each side. 1.3 Anti-scatter grid with a density ≥ 30 l/cm. 1.4 System for additional breast retraction into the acquisition field for better analysis. State the name of the offered option. 2 Generator 2.1 Built into the stand of the device due to space limitations. 2.2 High-frequency generator ≥ 100 kHz. 2.3 Maximum power ≥ 4.5 kW. 2.4 Maximum mAs value ≥ 600 mAs to obtain high-quality images even for high-density and large-sized breasts. 2.5 Maximum mA value ≥ 120 mA. 2.6 kV range: minimum range from 23 to 35 kV. 2.7 Separate exposure mode for breasts with implants. 2.8 Automatic power supply voltage compensation. 3 X-ray Tube Assembly Holder 3.1 Motorized rotation range ≥ 315°. 3.2 Isocentric motorized rotation of the C-arm so that the center of the detector always remains at the same height, reducing patient positioning time. 3.3 Heat capacity of the X-ray tube assembly holder ≥ 700 kHU. 3.4 Source-to-image receptor distance (SID) ≥ 65 cm to allow higher geometric resolution and easier patient positioning. 3.5 Manual and automatic adjustment of breast compression. 3.6 Automatic motorized collimator adjustment. 3.7 Compression plate with minimum dimensions of 18 x 23 cm. 3.8 Compression plate with minimum dimensions of 24 x 30 cm. 3.9 Display of adjusted exposure parameters: kV, mAs, compression force, and breast thickness. 3.10 Automatic exposure control. 3.11 Automatic and manual release of compression plates after imaging. 3.12 Magnification factor minimum 1.6x. 4 X-ray Tube 4.1 Minimum two focal spots; small focal spot not larger than 0.1 mm; large focal spot not larger than 0.3 mm. 4.2 Rotating anode. 4.3 Anode rotation speed ≥ 9600 rpm. 4.4 Anode heat capacity ≥ 300 kHU. 4.5 Dual motorized filters. 4.6 Automatic and manual collimation. 4.7 Automatic identification of attached compression plates and FOV adjustment. 5 Detector 5.1 New generation digital detector made of amorphous selenium or amorphous silicon with cesium iodide. 5.2 Active area size of the detector minimum 230 mm x 295 mm. 5.3 Image matrix resolution minimum 2800 x 3580 pixels. 5.4 Pixel size ≤ 85 µm. 5.5 Must be capable of operating within a minimum temperature range of 13°C to 35°C to ensure seamless system operation under local conditions. 5.6 A/D conversion minimum 16 bit. 5.7 Spatial resolution minimum 6 lp/mm. 6 Acquisition Station 6.1 Computer with minimum 8GB RAM. 6.2 Internal storage (Hard drive or SSD) minimum 1TB size. 6.3 Internal storage capacity for a minimum of 40,000 images on the acquisition workstation. 6.4 DICOM monitor with a minimum size of 23 inches and minimum resolution ≥ 2 megapixels. 6.5 Saving images to CD/DVD in DICOM format or equivalent. 6.6 Measurement of lengths and distances. 6.7 Image orientation labeling. 6.8 Zooming into the region of interest on the image. 6.9 Adding comments to the image. 6.10 Image inversion. 6.11 DICOM MPPS or equivalent. 6.12 DICOM Worklist Management or equivalent. 6.13 DICOM Print or equivalent. 6.14 Required time for image display not longer than 6 seconds. 6.15 Required time to obtain the final image not longer than 10 seconds. 6.16 Separate post-processing mode for breasts with implants. 6.17 Noise reduction tool. 6.18 Protective lead glass integrated into the control console, featuring a height-adjustable workspace to ensure greater ergonomics for the operator, providing radiation protection equivalent to a minimum of 0.5 mm Pb. 7 Diagnostic Workstation 7.1 Computer with minimum 32GB RAM. 7.2 Internal storage (Hard drive or SSD) minimum 1TB size. 7.3 Two monitors with a minimum size of 21 inches, matrix minimum 2560x2048 pixels, minimum resolution ≥ 5 megapixels. 7.4 Saving images to CD/DVD. 7.5 DICOM Print or equivalent. 7.6 Automatic alignment of images. 7.7 Paired display tool with zoom, pan, and magnification features. 7.8 Inverted tissue display without a bright background. 7.9 Tools for annotation and measurements. 7.10 Display of breasts without empty space between them. 8 Additional Options 8.1 Upgradable with hardware and software for Digital Breast Tomosynthesis (DBT). 8.2 Upgradable with a stereotactic biopsy system. ________________________________________ Terms and Conditions: ● Marketing Authorization for the medical device issued by the Agency for Medicines and Medical Devices of the Republic of North Macedonia (MALMED), in accordance with the Law on Medicines and Medical Devices. ● Equipment warranty for a minimum period of 2 (two) years, during which the economic operator is obliged to provide free servicing and free replacement of spare parts according to the recommendations of the manufacturer of the offered device. ● Mandatory submission of a completed technical specification. ● Mandatory submission of a completed manufacturer's catalog/brochure with clearly highlighted features of the offered product according to the requirements and sequential numbers in the technical specifications. ● Bids that do not contain a catalog and detailed marked characteristics will not be evaluated. ● Upon delivery of the system, the Economic Operator must perform its installation, as well as technical training for the staff of the Contracting Authority on its usage. ● Provided service center in the Republic of North Macedonia, with a service technician who has completed training for the offered model and holds a valid certificate issued by the manufacturer.