DENSITY SERIES

DENSITY SERIES

DENSITY SERIES

Product catalog summary
Overview: The document provides detailed specifications and certifications for the DEXA bone densitometer series by Eurotec Medical Systems, an Italian company specializing in X-ray devices. The document outlines the compliance with EU Regulation 2017/745 and the features of various models in the Density series.
Certification: Eurotec Medical Systems is certified under the EU Quality Management System Certificate No. 104/MDR, issued by IMQ S.p.A. as Notified Body No. 0051. The certification ensures compliance with EU medical device regulations and is subject to regular surveillance.
Device Specifications: The Density series includes models such as Density PB, Density NFB, Density S, and Density S-NFB, each utilizing different beam technologies (Pencil Beam and Narrow Fan Beam) and detector configurations. Key specifications include scan times, patient dose, dimensions, and patient weight capacity.
Software and Technology: The devices feature the dVision software, designed for ease of use with automatic tools for quick scans. The software supports multiple languages and includes modules for body mass composition analysis. It is compatible with Windows operating systems and requires specific hardware configurations.
Performance and Safety: The bone densitometers are designed to minimize radiation exposure while maintaining high image quality. They do not require external shielding, and the environmental dose rate is kept below 0.5µSv/h. The devices are equipped with automatic quality control and system diagnostics.
Clinical Application: The DEXA bone densitometry is used for diagnosing osteoporosis, a condition characterized by brittle bones. The World Health Organization's definitions based on Bone Mineral Density (BMD) are used to classify bone health into categories such as normal, osteopenia, osteoporosis, and severe osteoporosis.
Additional Features: The devices are designed for accessibility, with a low table height for easy access by disabled and elderly patients. They include features like automatic segmentation, single-window operation, and remote assistance capabilities.
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Catalog excerpts

DENSITY SERIES-1

DENSITY SERIES *Time and effective exposure depend on patient’s morphology EUROTEC MEDICAL SYSTEMS s.r.l. is one of the most important companies in Italy designing and mtanufacturing X-ray devices. Eurotec Medical Systems units are designed, developed and manufactured in ITALY, aiming to the most innovative technological and mechanical solutions. EUROTEC MEDICAL SYSTEMS is ISO 13485 - MDR n. 104 certified. j^eurotec medical systems A different DEXA bone densitometer Principle of operation: Separation: samarium filtered (K-edge) External shielding: Not required: x-ray safety requirements may be different in some countries Environmental Dose Rate: <0.5|jSv/h for typical usage @1m from x-ray source Reporting results: BMD, BMC, area, Z-score, T-score, Z-Score %, T-Score % Reference curves: NANHES, local databases Calibration: multi-points BMD and area Continuous Electronics Autocalibration: adaptive peak threshold setting Linearity range: 0,2g/cm2 s 2g/cm2 Patient weight limit: 203kg X-ray generator: Type: x-ray monobloc, HF, fixed anode, microprocessor controlled stability Constant potential source at 86keV Collimator: single hole /multiple holes, 2mm diam. X-ray detector: Type: ultra high efficiency NaI(Tl) scintillator integral line PMT Detector HV : negative, -200 to -1200V, stabilized Environmental requirements: Temperature: 15 to 27°C Humidity: 15% to 80% (non condensing) Minimum room dimensions: 3x3m Power requirements: 230VAC, 500W Software: Protocols: spine, Femur (right/left), Forearm (right/left), Total Body/Body composition (PB and NFB models), Pediatric (optional) Dicom 3.0 compliant (optional) Built-in automatic QC procedures and system diagnostics Bone edge detection: automatic Selectable quality (High resolution, Normal, Fast) Pre-set exam parameters automatically adjusted according to patient’s morphology PC and OS minimum requirements: Operating system: windows 64 - bit (7/8/8.1/10) Memory: 4GB Hard disk: 500GB Printer: inkjet or laser color Connection: Ethernet or 802.1n Wi-Fi (optional) Accessories: Washable and anallergic mattress Washable and anallergic pillow Covering clothes A bone densitometer for all: Easy to access for disabled and elderly with mobility problem. Table height is just 60cm. CERTIFIED COMPANY EU QUALITY MANAGEMENT SYSTEM CERTIFICATE CERTIFIED COMPANY DISTRIBUTOR s hotfffad Body no. 0051 i to medical devic What is the best business card a company can show if not the new European regulation on medical devices EU 2017/745. Eurotec is the only ITALIAN company with Medical Device Regulation

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DENSITY SERIES-2

OSTEOPOROSI a Osteoporosis is a medical condition in which the bones become brittle and fragile from loss of tissue, typically as a result of hormonal changes, or deficiency of calcium or vitamin D. Osteoporosis is one of the major diseases affecting the elderly and more precisely is the seventh most common complaint. The incidence among people over age 50 is about 50% mostly among women. b a: Normal bones - b:Osteoporosis DENSITY SERIES essential design The smart Density software Density series are the first bone densitometers to employ the patented suspended dVision is a totally new software,...

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All Eurotec Medical Systems catalogs and technical brochures

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