H - 6 Operator’s Manual
H Acoustic Output
• Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, June 27, 2019.
Center for Devices and Radiological Health.
• Medical electrical equipment-Part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment issued by
IEC in 2015
• IEC 62359, Ultrasonics-Field characterization-Test methods for the determination of thermal
and mechanical indices related to medical diagnostic ultrasonic fields, 2017.