P.
5
The device is intended to be prescribed by licensed
medical professionals. The device may be used on
patients during a physical assessment in a clinical
setting or by patients with a prescription and under the
supervision of a clinician. 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.
DUO should be used only by qualified clinicians or
prescribed to patients with an adequate understanding
of the device. DUO is intended for use on patients
that can be auscultated on normally with an acoustic
stethoscope.
This manual provides instructions for the use of
DUO and the Eko App. It is assumed that the user is
familiar with basic mobile application use on iOS™ and
Android™ devices.
Standard procedures for auscultation should be
followed including background noise reduction and
optimal patient positioning. The quality of the ECG is
dependent on proper preparation practices including,
but not limited to, patient body temperature and clean
contact area.
The device uses a Bluetooth Class 2 wireless data
link. The Bluetooth range will be reduced when
objects (walls, furniture, people, etc) are between DUO
and a paired mobile device. To improve Bluetooth
connection, reduce the distance and/or allow a line of
sight between DUO and the mobile device.
In order to transmit sounds and record electrical
activity to the Eko App, DUO and the mobile device
must be connected via Bluetooth, and in order to
fully use certain functions, the mobile device must be
connected to the internet.
It is highly recommended that users of the mobile
App and web Dashboard use device and networking
security features to protect patient data created and
stored using this software, in addition to security
features embedded in the system.
NOTICE:
Some of the features of the Eko App require
a minimum internet connection speed. The minimum
recommended upload speed for the mobile app
is 4000 Kbps. 4G cellular data service or similar is
recommended for the App.
The app can be used to visualize waveforms and
tracings without an internet connection, however an
internet connection is necessary to save the data.
1.8
Precautions
Summary of Contents for DUO E5
Page 1: ...User Manual Model E5...
