Usage
The AeviceMD Device is a non-invasive device intended to longitudinally acquire, record and store chest sounds. The AeviceMD Monitoring System is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the chest area, reported as wheeze. It is also intended to provide continuous measurement of heart rate and respiratory rate. The device stores these data which can be viewed by users on a mobile app and for later playback, review, and analysis by healthcare professionals on a Web App. The AeviceMD Monitoring System is intended for patients aged 3 years and above.
Contraindications
The AeviceMD Device should not be used on non-intact, non-healthy skin. This includes the following: rashes, open sores, lesions, cuts, scratches, scabs, burns, and blisters.
Cautions
This chapter outlines the Cautions associated with using and operating the AeviceMD. Read this chapter before using or operating the AeviceMD for the first time.
Cautions
Within the United States of America, federal law restricts this device to sale by or on the order of a physician; and use is restricted to, by, or on the order of a physician.
Precautions
The AeviceMD is not intended as a stand-alone diagnostic monitor for vital signs, cardiovascular diseases, pulmonary diseases, and cardiopulmonary diseases. The data provided by the AeviceMD is intended to aid in the evaluation process of the patient’s health by a healthcare professional. The AeviceMD is not an apnea monitor.
The AeviceMD Sensor may be unsuitable for patients using a pacemaker.