EchoNous KOSMOS - Chapter 9: Safety; Electrical Safety and Labeling Symbols; Biological Safety, ALARA, and Measurement Accuracy; Ergonomics and Electromagnetic Compatibility

Getting Started
2 KOSMOS User Guide
 KOSMOS User Guide
 KOSMOS Quick Start Guide
 KOSMOS UI Quick Guide
 ALARA education program (ISBN 1-932962-30-1, Medical Ultrasound
Safety)
 “How To” and clinical videos
 Terms and conditions of warranty
 Manufacturer Disclosure Statement for Medical Device Security (MDS2)
 DICOM Conformance Statement
Intended users
KOSMOS is intended to be used by qualified and trained healthcare
professionals that are legally authorized by law in the country, state, or other
local municipality in which they practice to use the device. The list of the
potential users includes but is not limited to (based on title/geographical
location): Medical specialists, primary care physicians, point-of-care users,
sonographers, medical healthcare technicians, nurses, nurse practitioners,
physician assistants, and medical students.
Users may or may not be working under supervision or authority of a physician.
Intended use/indications for use
KOSMOS is intended to be used by qualified and trained healthcare
professionals in the clinical assessment of the cardiac and pulmonary systems
and the abdomen by acquiring, processing, displaying, measuring, and storing
synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital
auscultation (DA) sounds and waveforms.
With respect to its ultrasound imaging capabilities, KOSMOS is a general purpose
diagnostic ultrasound system used in the following clinical applications and
modes of operation:
To help ensure the diagnostic quality of the images obtained, all patient
images must be obtained by qualified and trained healthcare
professionals.