Eko Devices E5 EKG and digital stethoscope device(BLE) User Manual

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Document Description	Users Manual
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Date Submitted	2017-11-22 00:00:00
Date Available	2018-05-15 00:00:00
Creation Date	2017-04-18 16:52:44
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User Manual, Model E5
1.1
Introduction, Warnings, and Safety
1.2
For Help and Assistance
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).
For general and product related comments, questions,
or concerns, please contact Eko Devices, Inc. directly
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.
Eko Devices, Inc.
2600 10th St. Suite 260
Berkeley, CA 94710
USA
CAUTION: Federal (USA) law restricts this device to
sale to or on the order of a clinician.
1.3
Safety Related Labels & Symbols
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.
Please report any injury or adverse event to Eko using
any of the contact methods below.
General Assistance and FAQs
ekodevices.com/getstarted
Direct Contact
support@ekodevices.com
Phone Support
1.844.356.3384
Product Reference and Information
www.ekodevices.com
This product and packaging does not contain
natural rubber latex.
LATEX
This product contains an intentional RF
radiator certified by the FCC.
REF
Catalog Number
LOT
Lot Number
SN
Serial Number
95%
10%
10° C
50° F
45° C
113° F
NON
STERILE
Humidity Limit (Operational)
Temperature Limit (Operational)
This product is provided non-sterile. Do not
attempt to re-sterilize the device.
This product uses wireless Bluetooth
communication
BF Applied Part
Contents (Quantity)
IP55
Protection against dust and water jets when
earpieces are attached.
The earpieces are not IP protected.
MR Unsafe
P.
1.4
Caution
P.
CAUTION
•
To reduce the risk of device interference, keep
DUO at least 2 meters away from all RF emitters
including Wifi routers and radios when operating
or charging.
•
To reduce the risks associated with infection
follow all cleaning and disinfecting instructions
included in this manual. Establish and follow a
cleaning and disinfecting schedule after each use.
•
To reduce the risks associated with inaccurate
data acquisition store and operate this device only
as instructed in this manual. It is recommended
that the battery be recharged within thirty minutes
of the LED indicator turning red. Recharge the
battery using only the wireless charging pad
provided with the device.
•
•
•
DO NOT immerse the device in a liquid or subject
it to any sterilization processes other than those
described in this manual. The device is non-sterile.
To reduce the risks associated with very strong
electromagnetic fields avoid using the device
near strong radio frequency (RF) signals or
portable and/or mobile RF devices. If sudden
or unexpected sounds are heard, move away
from any radio transmitting antennas. Using
accessories, transducers, and cables not
produced by Eko may result in increased RF
emissions or decreased immunity of DUO.
Please read, understand, and follow all safety
information contained in these instructions prior
to using DUO. It is recommended that these
instructions be retained for future reference.
•
•
DUO contains a Bluetooth Class 2 wireless
data link. The maximum radio frequency field
strength generated by the device is below three
volts per meter, a level that is considered safe to
use with other medical devices. However, audio,
video, and other similar equipment may cause
electromagnetic interference. If such devices are
encountered and cause interference, immediately
move DUO away from that device and/or turn the
Bluetooth feature OFF.
To reduce the risks associated with
environmental contamination follow applicable
regulations when disposing of this device. DUO
contains a rechargeable battery; please properly
dispose of the device as mandated by local
directives.
•
No modification of this equipment is allowed.
There are no repairable parts inside DUO.
•
Disperse any static electricity before using the
unit.
•
•
Warning: MR-unsafe! Do not expose the device
to a magnetic resonance (MR) environment. The
device may present a risk of projectile injury due
to the presence of ferromagnetic materials that
can be attracted by the MR magnet core. Thermal
injury and burns may occur due to the metal
components of the device that can heat during
MR scanning. The device may generate artifacts
in the MR image. The device may not function
properly due to the strong magnetic and radio
frequency fields generated by the MR scanner.
This device does not detect or measure all heart
rate, heart rhythm and heart waveform changes.
•
The device has not been tested for use on infants
weighing less than 10kgs.
•
Conductive parts of electrodes and associated
connectors for Type BF Applied Parts, including
the neutral electrode, should not contact other
conductive parts including earth.
•
Do not use DUO while it is charging.
•
Do not use on patients with cardiac pacemakers
or other electronic implanted devices.
•
Do not use the DUO on a portion of the body with
too much body fat, body hair or very dry skin, a
successful recording may not be possible.
•
Do not use DUO while charging your mobile
device, this will cause electrical interference with
the ECG signal.
•
Do not store the DUO in extremely hot, cold,
humid, or wet conditions.
•
Do not expose to strong electromagnetic fields.
•
Do not use as sole basis for medication or
treatment decisions.
•
Do not take a recording if the electrodes are dirty.
Clean them first.
•
Do not use the DUO over broken skin or wound
areas.
1.5
Skin Preparation
1.6
EMC Compliance
1.7
Cleaning
Excessive hair, dirty skin, dry skin, or oily skin can
impact the quality of the ECG tracing. Clean the
patient's skin with water and soap and remove excess
hair as needed to achieve the highest quality tracing.
Do not use the DUO over wound areas or areas of
broken skin. Do not use an alcohol based skin cleaner
as this dries out the patient's skin and increases
resistance. Dry the skin vigorously to increase capillary
blood flow to the tissues.
FCC Intentional Radiator Certi ication
To ensure a proper ECG and PCG recording, clean the
electrodes with an alcohol-based cleaning solution
prior to use.
ECG gels or saline solutions can be used on the
electrodes to improve signal quality.
RSS-GEN, Sec. 7.1.3
This device complies with Industry Canada licence-exempt RSS
standard(s). Operation is subject to the following two conditions:
(1) this device may not cause interference, and (2) this device must
accept any interference, including interference that may cause
undesired operation of the device.
Le pr sent appareil est conforme aux CNR d’Industrie Canada
applicables aux appareils radio exempts de licence. L’exploitation est
autoris e aux deux conditions suivantes : (1) l’appareil ne doit pas
produire de brouillage, et (2) l’utilisateur de l’appareil doit accepter
tout brouillage radio lectrique subi, m me si le brouillage est
susceptible d’en compromettre le fonctionnement.
Caution: Any changes or modifications to this device not explicitly
approved by manufacturer could void your authority to operate
thisequipment.
Attention: Les changements ou modifications de cet appareil non
express ment approuv par le fabricant peuvent annuler votre droit
utiliser cet quipement.
FCC ID: 2ANB3-E5
IC:23063-E5
This equipment contains an intentional radiator
approved by the FCC under the FCC ID numbers
shown above. This device complies with Part 15 of
the FCC rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any
interference received, including interference that may
cause undesirable operation.
NO MODIFICATION: Modifications to this device
shall not be made without the written consent of Eko
Devices, Inc. Unauthorized modifications may void
the authority granted under Federal Communications
Commission rules permitting the operation of this
device.
EMC Compliance Europe
This equipment complies with the EMC requirements
of the IEC 60601-1-2.
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.
P.
P.
1.8
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 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.
1.9
Indications for Use
1.10
Patient Privacy
1.11
Contents and Operation
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 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.
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
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.
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.
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.
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.
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.
P.
2.1
Setup
2.2
Charging
P.
Install included EARPIECE by plugging the audio jack
into the 3.5mm audio port at the base of DUO and
tightening the threads.
To charge DUO, place the device on the Wireless
Touch Charging Pad. Connect the charging pad to a
power source using the included USB charging cable
and power adapter. The LED light ring on DUO will
begin to flash to signal the charging status. All of
the LEDs in the ring will light up when the device is
fully charged. DUO should be periodically recharged
even when in storage. Lithium ion batteries slowly
lose charge when in storage and may fall to an
unacceptably low level, damaging the battery.
NOTE: DUO will not operate or connect to the Eko App
while charging.
EARPIECE
Wireless Touch Charging Pad
Micro USB
3.1
DUO Use
P.
DUO is controlled using the action button located on the top face. An LED ring illuminates when the device is powered on.
–
2s
To
Do This
LED Ring Response
Power On / Off
Press and hold the action
button for two seconds.
The active LED turns on/off
Change audio filters
Press the action button once.
The active LED rotates to a new
position corresponding to the
filter type.
Power Save Mode
DUO will automatically power off after 5 minutes of continuous inactivity. To resume DUO, press and hold the action button
for two seconds.
Volume Control
The device’s sound level can be amplified in 12 increments. Change the volume level by pressing the top (+) and bottom (-) of
the volume button on the side of the device. Increasing the volume by one level can be confirmed by the increasing number
of LEDs lit in the LED ring.
3.2
DUO Use
P.
The device is OFF. All functions
of the device are disabled.
The device is ON and has low
battery. The red warning LED
turns on. Device functions
normally.
The device is ON but not
paired. Active LED blnks
every 1.5 seconds. The device
is discoverable and ready to
connect via Bluetooth.
The device is ON and its
battery level is below 10%.
The LED flashes rapidly for 4
seconds, then turns off. The
device will no longer stream or
playback audio or ECG.
The device is ON and paired
with a phone/tablet. Active
LED is lit and solid. The device
is streaming live audio and
ECG to the paired device.
The device is OFF and is
charging. The percent of
charge completed is indicated
by the fullness of the LED ring.
The device is ON and playing
back sounds and waveforms
from a paired phone/tablet.
LEDs in LED ring light up based
on volume level.
The device is OFF and fully
charged. This is indicated by
an LED ring with all 12 of the
LEDs lit and solid.
The device is ON. The filter
change is indicated by the
active LED in the LED ring
rotating to a new position.
3.3
DUO Use
P.
10
DUO can be used on various locations and
orientations of the chest. Each position will produce a
unique heart sound and ECG tracing.
Electrodes
Diaphragm
PCG
Capture sounds by placing DUO anywhere on the
body. For best audio, press the device firmly against
the skin to ensure good contact.
ECG
Capture ECG by placing and orienting DUO on the
chest. The optimal position to capture ECG data is at
an inward-facing 45° angle at the upper left pectoral
below the clavicle. If the patient has particularly dry
skin, body fat or hair, conductive gel used with other
ECG systems may be used to improve the quality of
the data.
5.1
Operating Conditions
6.1
Warranty
Environmental
The operating range of the Core is 10° to 40°C (50 to
113°F), and 10% to 95% relative humidity. The storage
and transport range is -10° to 60° and 10% to 95%
relative humidity. Acceptable pressure is 1 atm.
Eko provides a limited warranty for DUO.
Please visit ekodevices.com/warranty for a full
description of the warranty.
It is recommended to avoid exposure to extreme heat,
cold, solvents and oils. Extreme heats and colds will
negatively affect the lithium ion battery in the device,
and may affect battery life.
Operating Warnings
Failure to follow care and maintenance
recommendations could result in damage to the
internal components of the device. Internal damage
to the product could cause malfunction of the product,
possibly leading to complete loss of function. If
problems are encountered with the device, do not
attempt to repair it. Please notify our support team for
assistance.
P.
11
7.1
Eko App Use
Installation for iPhone®
Open the App Store® using a supported mobile device. Ensure
that the device is connected to the internet and search for the Eko
Stethoscope App. Follow the instructions to download the App and
wait until it has finished installing.
Installation for iPad®
Open the App Store® using a supported iPad model. Ensure that the
device is connected to the internet. When searching the app store
for the Eko Stethoscope App, make sure to select “iPhone Only”
from the search options. Follow the instructions to download the
App and wait until it has finished installing.
P.
12
Log In with Username and Password
Open the Eko App on the mobile device. When prompted, create a
new account, or enter your existing username and password.
Bluetooth Pairing
Bluetooth must be enabled in the smartphone or tablet’s Bluetooth
settings in order to use the device with the Eko App.
Log in with PIN
New users are encouraged to set up a 4-digit login PIN to simplify
the login process on the Eko mobile app.
First, enable Bluetooth on the selected mobile device. On the
iOS device go to Settings > Bluetooth > and tap the slider to turn
Bluetooth ON.
To create or edit a login PIN manually, select the Menu icon on the
top left of the home screen. Select Account Settings > PIN and
follow the onscreen instructions. To modify your PIN, you need to
enter the number twice for verification purposes.
Open the Eko App and login to your account. Press "Connect Device"
and follow the onscreen instructions to pair with your DUO.
For more information, visit http://ekodevices.desk.com/customer/
en/portal/articles/1992653-how-do-i-download-the-eko-app-
AT&T
89%
1:45 PM
tap in your code
GHI
ABC
JKL
DEF
MNO
PQRS
TUV
WXYZ
Email
Delete
The mobile device is now ready to record sounds and display
waveforms from DUO. If Bluetooth pairing is unsuccessful, an error
message will appear in the App and no sounds will be recorded. If
Blueooth pairing is successful a waveform will be displayed on the
app.
7.2
Eko App Use
P.
13
Capture & Save Recordings using the Mobile App
Open the Eko Mobile App and log in. Ensure that DUO
is paired to the mobile device (See Bluetooth Pairing).
To associate the recording with a body position, select
the target icon on the top center of the screen. Use
the figure and icons to select the most appropriate
position.
Press the circular button to begin recording. Press the
square button (in the same location as start button) to
stop and save the recording.
AT&T
1:45 PM
89%
Adding Notes to Recordings on Mobile App
To create notes on any patient recordings, log into
the mobile application. Access the list of patients
by selecting the patients tab on the top right of the
home screen. Select the desired patient and select a
recording to add notes to.
Scroll to the bottom of the recording screen. Select
“Add Comment” and begin typing your note. Select the
the check mark to save.
AT&T
Hill, Thomas
1:45 PM
89%
Crouch, Tyler
Heart - Aortic
Add Note…
Crouch, Tyler
June 6, 2016 - Aortic
00:0000:00
Sharing from the Eko Mobile App
Patients and recordings can be shared to other
clinicians and collaborators within the Eko App.
Navigate to the patient list by selecting the top right
tab and selecting the patient to be shared. Select the
sharing icon on the top right of screen and select the
preferred method of sharing. Press the checkmark to
complete the process.
NOTE: Only the original creator of a patient account
is granted access to share patient profile with a
collaborator.
7.3
Main Recording Screen
The Main Recording Screen allows users to view
audio data captured by the device, begin the recording
process, retrieve patient-specific data, or adjust
settings. Audio data is represented in real-time as a
phonocardiogram and the ECG waveform. The grid
behind the waveform denotes 25mm/s and 10mm/
mV.
P.
14
Recording Setup
Select Position
AT&T
Settings
Modify Bluetooth
Adjust Volume
Change Audio Source
iPhone speakers or DUO
Earpieces
Adjust Account Details
Name
Username
Password/PIN
Contact Information
1:45 PM
Hill, Thomas
89%
Patient Selection
Create a patient-specific recordings
Review patient records
Import patients from select EHR
systems
ECG Waveform
Retrieved from device
Audio Waveform
Retrieved from device
Tap to Record
7.4
Settings Screen
The Settings icon on the Main Recording Screen
allows the user to access Bluetooth pairing to the
device, remaining battery charge level of a connected
device, playback volume, view mode, grid settings, and
audio filter modes. The Settings screen also allows
users to change email and password information or
set a login PIN. The PIN allows for quicker access to
the Eko App. Setting a PIN is recommended so that
users do not have to enter full login information each
time the App is opened. Finally, users may log out of
the App from this screen.
P.
15
My Devices
Connect to DUO or CORE
Audio Settings
Adjust Volume
Change Audio Source
iPhone speakers or DUO
Live Stream
Turn Livestream ON/OFF
Share Livestream Link
Support
Help (Link to www.
ekodevices.com/support)
Account
Modify Name
Modify Username
Modify Password and PIN
Update Contact
Information
Log Out
My Devices
Audio Settings
Live Stream
Help
Account
V 2.12.1.34.1
Connect
Return to Previous Screen
7.5
Patients Screen
Selecting the Patient Search icon on the main
screen brings up the patient list and search bar.
Patients appear in alphabetical order by default. The
search bar narrows the list to entries containing the
alphanumerical digits entered. Selecting a patient
displays a list of all recordings associated with the
patient. Patients may be added to the list individually
through manual input or syncing with compatible EHR
services.
P.
16
AT&T
1:45 PM
89%
All Patients
Search
Add New Patient
Groups
Search Patient List
Anonymous
Aaberg, Mark
PS01CEP90784
Aortic stenosis pilot program
Abdelhamid, Sahithi
PS01CEP90784
Abril, Gabriella
PS01CEP90784
Accala, Manuel
PS01CEP90784
Tag or description to add context to the pati…
Adamente, Isabella
PS01CEP90784
Patient List
Hospital ID
Description Tag
7.6
Review Screen
This screen displays a waveform of each recording,
options to playback the sound, or add notes. Notes
may be added by any user with access to the patient’s
profile.
P.
17
AT&T
1:45 PM
89%
Patient Information
Crouch, Tyler
Heart - Aortic
Recording Data
Comments
NOTES
Crouch, Tyler
Martin6,Stemper
4:59pm
June
2016 - Aortic
00:0000:00
RRR Murmur heard and Indicated.
Martin Stemper 4:59pm
Can someone take a closer look at 01:57 for
me?
8.1
Electrical Safety
P.
18
Guidance and Manufacturer’s Declaration - Electromagnetic Emission
DUO is intended for use in the electromagnetic environment specified below. The user of DUO should assure that it is used
in such an environment.
Applicable Emissions Test
Compliance
Electromagnetic Environment- Guidance
RF emissions CISPR 11
Group 1
DUO uses RF energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
Warning: The use of accessories other than those
specified, with the exception of accessories sold by
Eko as replacement parts, may result in increased
emissions or decreased immunity of DUO.
Warning: DUO should not be used adjacent to or
stacked with other equipment. If adjacent or stacked
use is necessary, DUO should be observed to verify
normal operation in the configuration in which it will be
used.
8.1
Electrical Safety
P.
19
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
DUO is intended for use in the electromagnetic environment specified below. The user of the Eko DUO should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment-Guidance
Electrostatic Discharge
(ESD) IEC 61000-4-2
+/- 8 kV contact
+/- 8 kV contact
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at
least 30%
+/- 15 kV air
+/- 15 kV air
Electrical Fast Transient/
Burst
IEC 61000-4-4
+/- 2 kV for supply lines
+/- 1kV for input/output lines
+/- 2 kV for supply lines
+/- 1kV for input/output lines
Mains power quality should be that of a typical commercial or hospital environment
Surge
IEC 61000-4-5
+/- 1 kV line to line
+/- 2 kV line to earth
+/- 1 kV line to line
+/- 2 kV line to earth
Mains power quality should be that of a typical commercial or hospital environment
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
5% UT (95% dip in UT) for 0.5 cycles
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycle
<5% UT (>95% dip in UT) for 5 sec
5% UT (95% dip in UT) for 0.5 cycles
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycle
<5% UT (>95% dip in UT) for 5 sec
Mains power quality should be that of a typical commercial or hospital environment.
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial magnetic field or
hospital environment.
Conducted RF
IEC 61000-4-6
3 Vrms
150kHz - 80 Mhz
3 Vrms
150kHz - 80 Mhz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
80 Mhz to 2.5 Ghz
Portable and mobile RF communications equipment should be used no closer to any part of DUO, including cables, than the
recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
d = [ 3.5 / V1] √P
d = [ 3.5 / E1] √P 90 MHz to 800 MHz
d = [ 7 / E1] √P 800 Mhz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and
d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determxined by an
electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the
vicinity of equipment marked with the following symbol:
NOTE 1 - At 80 MHz and 800 MHz, the higher frequency range applies
NOTE 2 - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and is affected by absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To address the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which DUO is used exceeds the applicable RF
compliance level above, DUO should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating DUO.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
8.1
Electrical Safety
P.
20
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Eko Electronic Stethoscope System
DUO is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The user of DUO can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and DUO as recommended below, according to the maximum output power of the communications equipment.
Separation Distance According to Frequency of Transmitter (m)
Rated Maximum Output
Power of Transmitter (W)
150 kHz to 80 MHz
d = 1.2 √P
80 MHz to 800 MHz
d = 1.2 √P
800 MHz to 2.5 GHz
d = 2.3 √P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1.2
1.2
2.3
10
3.7
3.7
7.4
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d is meters (m) can be estimated using the equation applicable to the frequency of the transmitter,
where P is the maximum power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
www.ekodevices.com
© 2016 Eko Devices, Inc. All Rights Reserved
Eko, the Eko logo, and DUO are trademarks of
Eko. Other company and product names may be
trademarks of their respective owners.
LBL 009 B

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