Eko Devices Inc. E5 用户手册
P.
2
The Eko Model E5 System is designed to support
healthcare professionals in analyzing cardiac and
other internal organ sounds. The Eko Model E5
System includes a device capturing heart sounds
and ECG readings (herein referred to as DUO), a
smartphone application (App), and a web application
(Dashboard).
healthcare professionals in analyzing cardiac and
other internal organ sounds. The Eko Model E5
System includes a device capturing heart sounds
and ECG readings (herein referred to as DUO), a
smartphone application (App), and a web application
(Dashboard).
DUO features audio and ECG data transmission via
Bluetooth that allows the user to open and playback
sounds and visualize phonocardiograms (PCG) and
electrocardiograms (ECG) in a mobile application on
compatible iOS smartphones and tablets. The App
provides the ability to save audio recordings and
waveforms (PCG and ECG) within Electronic Health
Record (EHR) systems, share patient recordings with
other practitioners, and annotate notes on recorded
audio. Eko is intended for use on pediatric and adult
patients. The device is not intended for infants
weighing less than 10 kg.
Bluetooth that allows the user to open and playback
sounds and visualize phonocardiograms (PCG) and
electrocardiograms (ECG) in a mobile application on
compatible iOS smartphones and tablets. The App
provides the ability to save audio recordings and
waveforms (PCG and ECG) within Electronic Health
Record (EHR) systems, share patient recordings with
other practitioners, and annotate notes on recorded
audio. Eko is intended for use on pediatric and adult
patients. The device is not intended for infants
weighing less than 10 kg.
CAUTION: Federal (USA) law restricts this device to
sale to or on the order of a clinician.
sale to or on the order of a clinician.
For general and product related comments, questions,
or concerns, please contact Eko Devices, Inc. directly
or concerns, please contact Eko Devices, Inc. directly
Please report any injury or adverse event to Eko using
any of the contact methods below.
any of the contact methods below.
Eko Devices, Inc.
2600 10th St. Suite 260
Berkeley, CA 94710
USA
2600 10th St. Suite 260
Berkeley, CA 94710
USA
General Assistance and FAQs
ekodevices.com/getstarted
ekodevices.com/getstarted
Direct Contact
support@ekodevices.com
support@ekodevices.com
Phone Support
1.844.356.3384
1.844.356.3384
Product Reference and Information
www.ekodevices.com
www.ekodevices.com
1.1
Introduction, Warnings, and Safety
1.2
For Help and Assistance
Consult instructions for use.
This product contains electrical and
electronic components and must not be
disposed of using standard refuse collection.
Please consult local directives for disposal of
electrical and electronic equipment.
electronic components and must not be
disposed of using standard refuse collection.
Please consult local directives for disposal of
electrical and electronic equipment.
This product and packaging does not contain
natural rubber latex.
natural rubber latex.
This product contains an intentional RF
radiator certified by the FCC.
radiator certified by the FCC.
Catalog Number
Lot Number
Serial Number
Humidity Limit (Operational)
Temperature Limit (Operational)
This product is provided non-sterile. Do not
attempt to re-sterilize the device.
attempt to re-sterilize the device.
This product uses wireless Bluetooth
communication
communication
BF Applied Part
Contents (Quantity)
Protection against dust and water jets when
earpieces are attached.
The earpieces are not IP protected.
earpieces are attached.
The earpieces are not IP protected.
MR Unsafe
1.3
Safety Related Labels & Symbols
LATEX
10%
95%
45° C
113° F
10° C
50° F
NON
STERILE
SN
LOT
REF
IP55