Eko devices Duo e5 User manual

User Manual, Model E5

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).

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.

CAUTION: Federal (USA) law restricts this device to

sale to or on the order of a clinician.

For general and product related comments, questions,

or concerns, please contact Eko Devices, Inc. directly

Please report any injury or adverse event to Eko using

any of the contact methods below.

Eko Devices, Inc.

2600 10th St. Suite 260

Berkeley, CA 94710

USA

General Assistance and FAQs

ekodevices.com/getstarted

Direct Contact

[email protected]

Phone Support

1.844.356.3384

Product Reference and Information

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.

This product and packaging does not contain

natural rubber latex.

This product contains an intentional RF

radiator certied 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.

This product uses wireless Bluetooth

communication

BF Applied Part

Contents (Quantity)

Protection against dust and water jets when

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

LOT

REF

IP55

CAUTION

• To reduce the risk of device interference, keep

DUO at least 2 meters away from all RF emitters

including Wi 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 elds 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 eld

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 modication 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 elds 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 elds.

• Do not use as sole basis for medication or

treatment decisions.

• Do not take a recording if the electrodes are dirty.

Clean them rst.

• Do not use the DUO over broken skin or wound

areas.

1.4

Caution

1.5

Skin Preparation

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 ow to the tissues.

ECG gels or saline solutions can be used on the

electrodes to improve signal quality.

FCC Intentional Radiator Certication

Contains FCC ID: XXXXXXXXXX

Contains IC: XXXXXXXXXXXXXX

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: Modications to this device

shall not be made without the written consent of Eko

Devices, Inc. Unauthorized modications 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.

1.6

EMC Compliance

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.

1.7

Cleaning

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 signicant only when used in

conjunction with clinician oversight and consideration

of other relevant patient information.

DUO should be used only by qualied 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

The Eko Model E5 System is intended to be used by

healthcare professionals to electronically amplify,

lter, 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 signicant 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

identiable 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

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 ash 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.

2.1

Setup

2.2

Charging

Micro USBWireless Touch Charging Pad

EARPIECE

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 lters Press the action button once. The active LED rotates to a new

position corresponding to the

lter type.

3.1

DUO Use

DUO is controlled using the action button located on the top face. An LED ring illuminates when the device is powered on.

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 amplied 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 conrmed by the increasing number

of LEDs lit in the LED ring.

–

The device is OFF. All functions

of the device are disabled.

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 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 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 ON. The lter

change is indicated by the

active LED in the LED ring

rotating to a new position.

The device is ON and has low

battery. The red warning LED

turns on. Device functions

normally.

The device is ON and its

battery level is below 10%.

The LED ashes rapidly for 4

seconds, then turns off. The

device will no longer stream or

playback audio or ECG.

The device is OFF and is

charging. The percent of

charge completed is indicated

by the fullness of the LED ring.

The device is OFF and fully

charged. This is indicated by

an LED ring with all 12 of the

LEDs lit and solid.

3.2

DUO Use

3.3

DUO Use

DUO can be used on various locations and

orientations of the chest. Each position will produce a

unique heart sound and ECG tracing.

PCG

Capture sounds by placing DUO anywhere on the

body. For best audio, press the device rmly 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.

Electrodes Diaphragm

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.

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.

Eko provides a limited warranty for DUO.

Please visit ekodevices.com/warranty for a full

description of the warranty.

5.1

Operating Conditions

6.1

Warranty

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 nished 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 nished installing.

For more information, visit http://ekodevices.desk.com/customer/

en/portal/articles/1992653-how-do-i-download-the-eko-app-

Open the Eko App on the mobile device. When prompted, create a

new account, or enter your existing username and password.

New users are encouraged to set up a 4-digit login PIN to simplify

the login process on the Eko mobile app.

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 verication purposes.

Bluetooth Pairing

Bluetooth must be enabled in the smartphone or tablet’s Bluetooth

settings in order to use the device with the Eko 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.

Open the Eko App and login to your account. Press "Connect Device"

and follow the onscreen instructions to pair with your DUO.

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.

7.1

Eko App Use

W X Y Z

T U V

P Q R S

M N O

J K L

G H I

D E F

A B C

0DeleteEmail

tap in your code

89%

AT&T

1:45 PM

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 gure 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.

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.

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 prole with a

collaborator.

7.2

Eko App Use

89%

AT&T

1:45 PM

Hill, Thomas

Crouch, Tyler

89%

AT&T

1:45 PM

Heart - Aortic

Add Note…

June 6, 2016 - Aortic

Crouch, Tyler

00:00

The Main Recording Screen allows users to view

audio data captured by the device, begin the recording

process, retrieve patient-specic 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.

7.3

Main Recording Screen

89%

AT&T

1:45 PM

Hill, Thomas

Settings

Modify Bluetooth

Adjust Volume

Change Audio Source

iPhone speakers or DUO

Earpieces

Adjust Account Details

Name

Username

Password/PIN

Contact Information

Audio Waveform

Retrieved from device

Tap to Record

ECG Waveform

Retrieved from device

Patient Selection

Create a patient-specic recordings

Review patient records

Import patients from select EHR

systems

Recording Setup

Select Position

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 lter 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.

7.4

Settings Screen

My Devices

Audio Settings

Live Stream

Help

Account

V 2.12.1.34.1

Connect

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

Return to Previous ScreenMy Devices

Connect to DUO or CORE

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.

7.5

Patients Screen

Aaberg, Mark

Anonymous

PS01CEP90784

Aortic stenosis pilot program

Adamente, Isabella

PS01CEP90784

Accala, Manuel

PS01CEP90784

Tag or description to add context to the pati…

Abril, Gabriella

PS01CEP90784

Abdelhamid, Sahithi

PS01CEP90784

All Patients

89%

AT&T

1:45 PM

Add New Patient

Groups

Search Patient List

Patient List

Hospital ID

Description Tag

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

prole.

7.6

Review Screen

Can someone take a closer look at 01:57 for

me?

Martin Stemper 4:59pm

RRR Murmur heard and Indicated.

Martin Stemper 4:59pm

This is one of the more complicated ab

cardiology characteristics. Will address

tomorrow.

You 4:59pm

NOTES

Add Note…

Crouch, Tyler

89%

AT&T

1:45 PM

Heart - Aortic

Thanks

Martin Stemper 5:05pm

June 6, 2016 - Aortic

Crouch, Tyler

00:00

Comments

Patient Information

Recording Data

June 6, 2016 - Aortic

Crouch, Tyler 00:00

00:00

Warning: The use of accessories other than those

specied, 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 conguration in which it will be

used.

Guidance and Manufacturer’s Declaration - Electromagnetic Emission

DUO is intended for use in the electromagnetic environment specied 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.

8.1

Electrical Safety

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

DUO is intended for use in the electromagnetic environment specied 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

+/- 15 kV air

+/- 8 kV contact

+/- 15 kV air

Floors should be wood, concrete, or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at

least 30%

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 eld

IEC 61000-4-8

30 A/m 30 A/m Power frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial magnetic eld or

hospital environment.

Conducted RF

IEC 61000-4-6

3 Vrms

150kHz - 80 Mhz

3 Vrms

150kHz - 80 Mhz

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 xed RF transmitters, as determxined by an

electromagnetic site survey, ashould be less than the compliance level in each frequency range. bInterference may occur in the

vicinity of equipment marked with the following symbol:

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz

3 V/m

80 Mhz to 2.5 Ghz

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 reection from structures, objects and people.

a Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld 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.

b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

8.1

Electrical Safety

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.

Rated Maximum Output

Power of Transmitter (W)

Separation Distance According to Frequency of Transmitter (m)

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 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 reection from structures, objects and people.

8.1

Electrical Safety