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Assessing the diffusing capacity of the lungs for carbon monoxide (DLco) is one of the most clinically valuable tests of lung function and a commonly used endpoint in respiratory clinical trials. The Vitalograph® DLco solution enables reports from sites’ own equipment to be uploaded to the COMPACT™ Medical Workstation for inclusion alongside other study data, in a centralized respiratory data set. This approach minimises study device rental costs and equipment storage for sites.
DLco reports are manually uploaded to the COMPACT Medical Workstation by qualified site staff and sent to a central Vitalograph database. For quality assurance, Vitalograph clinical specialists over-read DLco data, providing accessible results and feedback to continuously improve site data, compliance and performance throughout the study.
|Dimensions||375mm x 235mm x 110mm|
|Communications||USB x minimum 6, Serial x 2, Ethernet x 2, DVI, WiFi|
|QA/GMP Standards||ISO 13485, FDA 21 CFR 820, SOR/98-282, JPAL, MDSAP|
|Voltage/Frequency||110-240 V; approximately 50/60 Hz|
|Performance Standards/Guidelines met or exceeded by the Vitalograph COMPACT Expert||ISO 23747, ISO 26782, ATS/ERS 2019|
|Flow detection principle||Fleisch type pneumotacograph|
|Back pressure||Less than 0.1kPa/L/second @ 14L/s, complies with ISO26782:2009|
|Volume accuracy||±2.5% or 0.05L|
|Flow accuracy||Flow ±10% or 0.3 L/s|