Eko Devices DUO E5, User Manual

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The Eko Model E5 System is intended to be used by
healthcare professionals to electronically amplify,
filter, and transfer body sounds and single-channel
electrocardiogram (ECG) waveforms. The Eko
Model E5 System also displays ECG waveforms and
phonocardiogram waveforms on the accompanying
mobile application for storage and sharing (when
prescribed or used under the care of a physician).
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. The
device can be used on adults and pediatrics.
The data offered by the device is only significant when
used in conjunction with physician over read as well
as consideration of other relevant patient data.
The device should not be used on infants weighing
less than 10kg.
1.9
Indications for Use
The privacy of patient health information may be
protected by state, federal, or international/foreign
laws that regulate how such information can be used,
stored, transmitted, and disclosed. The Eko system
employs security features that are compliant with
HIPAA policies. Third party access may be prohibited
to such information without obtaining written
authorization from the patient.
The user is fully responsible for understanding and
following all laws that regulate storage, transmission,
and disclosure of any electronic patient data through
the use of software. If the user becomes unable to
comply with a law or restriction that applies to use and
disclosure of such data, the user should not proceed
to collect or save such information.
This application may require entry of individually
identifiable health information in order to function.
Records are stored and recalled through the use of
patient name, date of birth, and/or patient ID number.
By entering this information, the user assumes any
and all risks of and liabilities incurred with using or
transmitting such information.
This package includes
(1) Eko DUO
(1) Wireless Touch Charging Pad
(1) 5W / 2A USB Power Adapter
(1) Micro USB to USB Cable
(1) Eko EARPIECE
(6) Silicone Rubber Eartips
(1) Getting Started Instruction Card
For full functionality, the system requires users to
connect their DUO with an internet-enabled smart
mobile device using the Eko App (not included). The
App supports many Apple® and Android™ mobile
devices.
NOTE: DUO can be used with other audio equipment
or headphones through the 3.5mm audio jack.
However, no performance guarantees are claimed
using other audio products.
System Requirements
The mobile app software can be used with iPhone®
4S, 5, 5C, 5S, 6, 6 Plus, 6s, 6SE, 6S Plus, iPad Mini™ 2,
3, iPad Air®/Air 2, and iPad® 3rd/4th generations with
iOS 7.0+ and at least 25MB of free memory.
DUO uses Bluetooth® Smart; mobile devices used
must be compatible with Bluetooth® Smart.
Apple®, iPhone®, iPad®, iPad Air®, and iPad Mini™ are
registered trademarks of Apple, Inc.
Bluetooth® is a registered trademark of Bluetooth SIG, Inc.
1.10
Patient Privacy
1.11
Contents and Operation