Warranty

1.6

Indications for Use

DES-I is intended to be used as a part of a physical

assessment

of a patient by healthcare professionals for

diagnostic decision

support in clinical settings. DES-I is

intended for use on pediatric

and adult patients. It can

electronically amplify, filter, and transfer sounds to the

accompanying mobile application for storage and sharing. It

can be used to record heart sounds and cardiac murmurs,

bruits, respiratory sounds and abdominal

sounds during

physical examination in normal patients or those with

suspected diseases of the cardiac, vascular, pulmonary or

abdominal organ systems.

There are no known contraindications for DES-I, although care

should be taken when considering using the device according

to the warnings and precautions below.

DES-I is not life-supporting or life sustaining.

1.7

Precautions

The device is intended to be prescribed by licensed medical

professionals for use on patients during a physical assessment

in a clinical setting. The system provides one source of

data that is significant only when used in conjunction with

clinician oversight and consideration of other relevant patient

information.

DES-I should be used only by qualified clinicians. DES-I is

intended for use on patients that can be auscultated on normally

with an

acoustic stethoscope.

This manual provides instructions for the use of DES-I and

mobile applications. It is assumed that the user is

familiar

with basic website navigation and mobile application

use on

iOS devices.

This device is only indicated for use in a hospital, physician’s

office, or other clinical setting. Standard procedures for