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1 The user level of expertise required is described in the Instructions for Use as the Intended Operator Profile.
2 3D reconstructions at higher resolution settings may take longer times
3 Söderman M, Holmin S, Andersson T, Palmgren C, Babic D, Hoornaert B. Image noise reduction algorithm for digital subtraction angiography: clinical results. Radiology. 2013 Nov;269(2):553-60.The results of the application of dose reduction techniques will vary depending on the clinical task, patient size, anatomical location and clinical practice. The interventional radiologist assisted by a physicist as necessary has to determine the appropriate settings for each specific clinical task. Results based on DSA dose area product per frame from a single center prospective randomized study on 20 patients. DSA runs for Allura Xper with ClarityIQ and Allura Xper without ClarityIQ were acquired on the frontal and lateral channel on the same patient under same condition of geometry, field of view, and injection protocol. Image quality was based on subjective assessment (score 1-5, 1=very poor, 5=excellent, blinded review by 3 radiologists involved in the study).
4 In a simulation study with over 60 users globally, results obtained during user tests performed in the period of November 2015-February 2016. The tests were designed and supervised by Use-Lab GmbH, an independent and objective usability testing engineering consultancy and user interface design company. The tests involved 31 US-based clinicians (16 physicians and 15 technicians) and 30 European-based clinicians (15 physicians and 15 technologists), who performed procedures using Azurion in a simulated interventional lab environment.