Cleaning; Precautions - Eko DUO Benutzerhandbuch

1.9 Cleaning

To ensure a proper ECG and PCG recording, clean
the electrodes with an alcohol-based cleaning
solution prior to use.
Cleaning and Disinfecting Procedure
The device and earpieces should be cleaned
between each patient use. All cleaning instructions
pertaining to stethoscopes and ECG units in general
apply.
Under normal conditions it is unnecessary to
separate the device from the earpieces for cleaning.
All external parts of the hardware can be cleaned
with 70% isopropyl alcohol wipes.
NOTE: DO NOT immerse the device in any liquid or
subject it to any high-pressure/autoclave sterilization
processes.

1.10 Precautions

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 normally with an
acoustic stethoscope.
This manual provides instructions for the use of DUO
and 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, cleaning the contact area and
using ECG gel.
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.
DUO - User Manual Pg 6
In order to transmit sounds and record electrical
activity to 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.
In addition to security features embedded in the
system, it is highly recommended that users of the
mobile app and web dashboard use networking
security features to protect patient data created
and stored using this software. Common examples
include, strong passwords, biometric authorization,
two-factor authentication, and VPN encryption when
available.
DUO is not intended to be used in conjunction with
OXYGEN RICH ENVIRONMENTS.
DUO is not intended for use with flammable
anaesthetic.
DUO is not intended for use with flammable agents.
NOTICE: Some of the features of 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.