How Can I Upload Documents Into The Eko App

Eko DUO

User Transmission

1.1 Introduction, Warnings, and Prophylactic
The Eko DUO Organization is designed to support healthcare professionals in analyzing cardiac and other internal organ sounds. The Eko DUO Arrangement includes a device capturing eye sounds and ECG readings (herein referred to as DUO), a smartphone awarding (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 uniform iOS smartphones and tablets. The App provides the ability to salvage audio recordings and waveforms (PCG and ECG) inside Electronic Health Record (EHR) systems, share patient recordings with other practitioners, and comment notes on recorded audio. Eko is intended for apply on pediatric and adult patients. The device is not intended for infants weighing less than ten kg.
CAUTION: Federal (USA) police restricts this device to sale to or on the club of a clinician.

1.2 For Assistance and Assistance
For general and production related comments, questions, or concerns, please contact Eko Devices, Inc. directly
Delight written report any injury or agin upshot to Eko using any of the contact methods below.
Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612 U.s.a.
Full general Aid and FAQs ekohealth.com/getstarted
Directly Contact [email protected]
Phone Back up 1.844.356.3384
Product Reference and Information www.ekohealth.com

1.3

Condom Related Labels & Symbols

Indicates the need for the user to consult the instructions for utilise.
This product contains electric and electronic components and must non be tending of using standard decline collection. Please consult local directives for disposal of electrical and electronic equipment.
This production and packaging does not contain
LATEX
natural rubber latex.
To signal generally elevated, potentially chancy, levels of nonionizing radiations, or to indicate equipment or systems e.g. in the medical electric surface area that include RF transmitters or that intentionally employ RF electromagnetic energy for diagnosis or treatment. This production contains an intentional RF radiator certified by the FCC.
REF Catalog Number
LOT Lot Number
SN Series Number
Indicates the range of humidity to which the medical device tin be safely exposed. (Operational)

i.iii

Safety Related Labels & Symbols (continued)

iii

Indicates the temperature limits to which the medical device can be safely exposed (Operational)

This product is provided non-sterile. Practice non effort to re-sterilize the device.

This product uses wireless Bluetooth advice

To place a type BF applied part complying with IEC 60601-ane

Contents (Quantity)

IP55

Protection against grit and water jets when earpieces are fastened. The earpieces are not IP protected.

Keep abroad from magnetic resonance imaging (MRI) equipment

Rx Simply Requires prescription in the United States.

Signifies European technical conformity 0537 (number is identification of notified body).
Indicates the medical device manufacturer.

EC REP Indicates the Authorized representative in the European Customs
Indicates the medical device manufacturing engagement.

1.four Caution
CAUTION
· To reduce the risk of device interference, keep
DUO at to the lowest degree ii 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. Constitute and follow a cleaning and disinfecting schedule later on each apply.
· To reduce the risks associated with inaccurate
data acquisition store and operate this device just as instructed in this transmission. It is recommended that the battery exist recharged within thirty minutes of the LED indicator turning red. Recharge the battery using merely the wireless charging pad provided with the device.
· Practice Non immerse the device in a liquid or field of study
information technology to whatever sterilization processes other than those described in this transmission. The device is not-sterile.
· To reduce the risks associated with very strong
electromagnetic fields avert using the device most strong radio frequency (RF) signals or portable and/or mobile RF devices. If sudden or unexpected sounds are heard, motion away from whatever radio transmitting antennas. Using accessories, transducers, and cables not produced by Eko may result in increased RF emissions or decreased immunity of DUO.
· Delight read, understand, and follow all safe
data contained in these instructions prior to using DUO. It is recommended that these instructions be retained for hereafter reference.

· DUO contains a Bluetooth Form 2 wireless
information link. The maximum radio frequency field forcefulness generated by the device is beneath three volts per meter, a level that is considered safety to use with other medical devices. Nonetheless, sound, 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 applicative 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 within 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 chance of projectile injury due to the presence of ferromagnetic materials that can exist attracted by the MR magnet core. Thermal injury and burns may occur due to the metallic components of the device that tin can oestrus during MR scanning. The device may generate artifacts in the MR image. The device may non function properly due to the strong magnetic and radio frequency fields generated past the MR scanner.
· This device does non detect or measure out all heart

P. 4
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 non contact other conductive parts including globe.
· Practise not use DUO while it is charging. · Do non 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, trunk pilus or very dry peel, a successful recording may not be possible.
· Do not use DUO while charging your mobile
device, this volition crusade electrical interference with the ECG signal.
· Practice not store the DUO in extremely hot, cold,
boiling, or wet conditions.
· Exercise non expose to strong electromagnetic fields. · Exercise not use equally sole basis for medication or
treatment decisions.
· Do not take a recording if the electrodes are muddy.
Clean them start.
· Do not use the DUO over broken skin or wound
areas.

1.5 Skin Preparation
Excessive hair, dingy skin, dry pare, or oily skin tin touch on the quality of the ECG tracing. Make clean the patient's skin with water and lather and remove backlog hair as needed to attain the highest quality tracing. Do non use the DUO over wound areas or areas of broken skin. Practice not use an alcohol based peel cleaner as this dries out the patient's peel and increases resistance. Dry the skin vigorously to increment capillary blood menses to the tissues.
ECG gels or saline solutions tin be used on the electrodes to improve signal quality.

1.half-dozen EMC Compliance
FCC Intentional Radiator Certification
Contains FCC ID: 2ANB3-E5 Contains IC: 23063-E5
This equipment contains an intentional radiator approved past the FCC under the FCC ID numbers shown higher up. This device complies with Part 15 of the FCC rules. Performance is subject to the following 2 atmospheric condition: (one) This device may non cause harmful interference, and (2) this device must accept any interference received, including interference that may crusade 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 performance of this device.
EMC Compliance Europe This equipment complies with the EMC requirements of the IEC 60601-1-2.

1.7

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 information technology is unnecessary to divide the device from the earpieces for cleaning. All external parts of the hardware tin can be cleaned with 70% isopropyl booze wipes.
NOTE: DO NOT immerse the device in whatsoever liquid or subject it to any high-pressure/autoclave sterilization processes.

i.eight

Precautions

half dozen

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 information that is meaning just when used in conjunction with clinician oversight and consideration of other relevant patient information.
DUO should exist used but by qualified clinicians or prescribed to patients with an adequate understanding of the device. DUO is intended for utilize on patients that tin can be auscultated on normally with an acoustic stethoscope.
This manual provides instructions for the employ of DUO and the Eko App. It is assumed that the user is familiar with bones mobile awarding use on iOSTM and AndroidTM devices.
Standard procedures for auscultation should exist followed including background noise reduction and optimal patient positioning. The quality of the ECG is dependent on proper training practices including, simply not limited to, patient body temperature and clean contact expanse.

The device uses a Bluetooth Course 2 wireless data link. The Bluetooth range volition be reduced when objects (walls, furniture, people, etc) are between DUO and a paired mobile device. To ameliorate Bluetooth connection, reduce the distance and/or allow a line of sight betwixt DUO and the mobile device.
In order to transmit sounds and tape electrical activity to the Eko App, DUO and the mobile device must be connected via Bluetooth, and in society to fully utilize sure functions, the mobile device must exist connected to the net.
Information technology is highly recommended that users of the mobile App and web Dashboard use device and networking security features to protect patient information created and stored using this software, in addition to security features embedded in the system.
Find: Some of the features of the Eko App crave a minimum internet connexion 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 exist used to visualize waveforms and tracings without an internet connection, however an internet connexion is necessary to save the data.

one.9 Indications for Use
The Eko DUO System is intended to exist used past healthcare professionals to electronically amplify, filter, and transfer body sounds and single-channel electrocardiogram (ECG) waveforms. The Eko DUO System besides displays ECG waveforms and phonocardiogram waveforms on the accompanying mobile awarding for storage and sharing (when prescribed or used nether the intendance of a physician). It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds, and intestinal sounds during physical test in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary, or intestinal organ systems. The device can exist used on adults and pediatrics.
The information offered by the device is simply significant when used in conjunction with doc over read likewise as consideration of other relevant patient information.
The device should non be used on infants weighing less than 10kg.

1.10 Patient Privacy
The privacy of patient health data may be protected by state, federal, or international/strange laws that regulate how such data can exist used, stored, transmitted, and disclosed. The Eko organisation employs security features that are compliant with HIPAA policies. Third party access may exist 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 constabulary or brake that applies to use and disclosure of such data, the user should not go along to collect or salvage such information.
This awarding may require entry of individually identifiable health information in order to function. Records are stored and recalled through the utilize of patient proper noun, date of nascency, and/or patient ID number. By entering this data, the user assumes whatever and all risks of and liabilities incurred with using or transmitting such information.

1.11

Contents and Performance

This parcel includes (1) Eko DUO (1) Wireless Bear upon Charging Pad (one) 5W / 2A USB Power Adapter (1) Micro USB to USB Cable (ane) Eko EARPIECE (6) Silicone Rubber Eartips (1) Getting Started Teaching Card
For full functionality, the organization 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 AndroidTM mobile devices.
NOTE: DUO can exist used with other audio equipment or headphones through the 3.5mm audio jack. Nonetheless, no performance guarantees are claimed using other audio products.
System Requirements The mobile app software can be used with iPhone® 5S and newer models, iPad MiniTM 2, 3, iPad Air®/Air 2, and iPad® tertiary/4th generations with iOS 11.0+ and at to the lowest degree 25MB of free memory.
The mobile app software can be used with Android OS 8 & greater.
DUO uses Bluetooth® Smart; mobile devices used must exist uniform with Bluetooth® Smart.
Apple®, iPhone®, iPad®, iPad Air®, and iPad MiniTM are registered trademarks of Apple, Inc.
Bluetooth® is a registered trademark of Bluetooth SIG, Inc.

ii.i Setup
Install included EARPIECE by plugging the sound jack into the 3.5mm audio port at the base of DUO and tightening the threads.

2.ii Charging
To charge DUO, place the device on the Wireless Touch Charging Pad. Connect the charging pad to a ability source using the included USB charging cable and power adapter. The LED light ring on DUO will begin to wink to signal the charging status. All of the LEDs in the ring will lite up when the device is fully charged. DUO should be periodically recharged even when in storage. Lithium ion batteries slowly lose accuse when in storage and may fall to an unacceptably depression level, damaging the bombardment.
NOTE: DUO will non operate or connect to the Eko App while charging.

EARPIECE

Wireless Touch Charging Pad

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Micro USB

3.1 DUO Use

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

To
+

Do This

LED Ring Response

2s Ability On / Off

Press and hold the action

The active LED turns on/off

push button for two seconds.

Alter audio filters

Printing the action push button 3 times quickly.

The active LED rotates to a new position corresponding to the

filter blazon.

Take a recording

Press the action button two times quickly. Printing one time to end recording. Recording will get-go afterward a 0.two second filibuster to prevent push button click audio from being included in the recording.
Recordings can likewise be initiated in the Eko App.

The active LED remains on.

Power Relieve Way DUO will automatically power off later on 5 minutes of continuous inactivity. To resume DUO, press and hold the action button for two seconds.
Volume Command The device's sound level can be amplified in 12 increments. Alter the volume level by pressing the pinnacle (+) and bottom (-) of the volume button on the side of the device. Increasing the book by one level can be confirmed by the increasing number of LEDs lit in the LED ring.

3.two DUO Employ

The device is OFF. All functions of the device are disabled.
The device is ON but not paired. Agile LED blnks every ane.5 seconds. The device is discoverable and gear up 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 sound and ECG to the paired device.
The device is ON. The filter change is indicated by the active LED in the LED ring rotating to a new position.

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The device is ON and has depression battery. The scarlet warning LED turns on. Device functions normally.
The device is ON and its bombardment level is below 10%. The LED flashes rapidly for iv seconds, then turns off. The device will no longer stream or playback audio or ECG. The device is OFF and is charging.
The device is OFF and fully charged.

3.iii

DUO Apply

Electrodes

Diaphragm

DUO can be used on various locations and orientations of the chest. Each position will produce a unique middle audio and ECG tracing.
PCG Capture sounds by placing DUO anywhere on the body. For all-time audio, printing 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° bending 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 amend the quality of the data.

5.1

6.1

Operating Weather

Warranty

Environmental The operating range of the DUO is 10° to twoscore°C (50 to 113°F), and 10% to 95% relative humidity. The storage and transport range is -x° to threescore° and 10% to 95% relative humidity. Acceptable pressure level is 1 atm.
It is recommended to avoid exposure to farthermost heat, cold, solvents and oils. Extreme heats and colds will negatively affect the lithium ion bombardment 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 non attempt to repair information technology. Please notify our support squad for assistance.

Eko provides a limited warranty for DUO. Please visit ekohealth.com/warranty for a total description of the warranty.

seven.i

Eko App Use

Installation for iPhone® Open the App Store® using a supported mobile device. Ensure that the device is continued to the internet and search for the Eko Stethoscope App. Follow the instructions to download the App and wait until information technology has finished installing.
Installation for iPad® Open the App Shop® using a supported iPad model. Ensure that the device is continued to the internet. When searching the app store for the Eko Stethoscope App, brand sure to select "iPhone Only" from the search options. Follow the instructions to download the App and wait until information technology has finished installing.

Log In with Username and Countersign Open the Eko App on the mobile device. When prompted, create a new account, or enter your existing username and password.
Log in with PIN New users are encouraged to prepare a 4-digit login PIN to simplify the login procedure on the Eko mobile app.
To create or edit a login Pivot manually, select the Bill of fare icon on the pinnacle left of the home screen. Select Account Settings > PIN and follow the onscreen instructions. To change your Pivot, you need to enter the number twice for verification purposes.

For more than information, visit https://support.ekohealth.com.

Bluetooth Pairing Bluetooth must be enabled in the smartphone or tablet's Bluetooth settings in social club 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 business relationship. 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 volition appear in the App and no sounds will be recorded. If Blueooth pairing is successful a waveform volition exist displayed on the app.

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seven.2 Eko App Utilize
Capture & Save Recordings using the Mobile App Open up the Eko Mobile App and log in. Ensure that DUO is paired to the mobile device (Encounter Bluetooth Pairing).
To acquaintance the recording with a trunk position, select the target icon on the tiptop heart of the screen. Use the effigy and icons to select the most appropriate position.
Press the round push button to begin recording. Printing the foursquare button (in the same location as start push) to stop and salve the recording.

Adding Notes to Recordings on Mobile App To create notes on any patient recordings, log into the mobile awarding. Admission 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 lesser of the recording screen. Select "Add together Note" and brainstorm typing your annotation. Select the the done button to save.

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Sharing from the Eko Mobile App Patients and recordings tin can be shared to other clinicians and collaborators within the Eko App. Navigate to the patient list by selecting the acme right tab and selecting the patient to be shared. Select the sharing icon on the tiptop correct of screen and select the preferred method of sharing. Press the checkmark to complete the process.
Annotation: Only the original creator of a patient business relationship is granted access to share patient profile with a collaborator.

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7.3 Primary Recording Screen
The Chief Recording Screen allows users to view audio data captured by the device, begin the recording process, call up patient-specific data, or adjust settings. Audio data is represented in real-time as a phonocardiogram and the ECG waveform. The filigree behind the waveform denotes 25mm/s and 10mm/ mV.

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Recording Setup Select Position
Settings Change Bluetooth Adjust Volume Change Audio Source
iPhone speakers or DUO Earpieces Adjust Account Details
Proper name Username Password/PIN Contact Data

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Patient Selection Create a patient-specific recordings Review patient records Import patients from select EHR systems
ECG Waveform Retrieved from device

Sound Waveform Retrieved from device

Tap to Record

7.four

Settings Screen

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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 style, grid settings, and audio filter modes. The Settings screen also allows users to alter email and countersign data or set a login PIN. The PIN allows for quicker access to the Eko App. Setting a PIN is recommended so that users practise not have to enter total login information each fourth dimension the App is opened. Finally, users may log out of the App from this screen.

Return to Previous Screen
My Devices Connect to DUO or Core
Play from iPhone Toggle ON/OFF for playing heart sounds on iPhone
Live Stream Plow Livestream ON/OFF
Business relationship Modify Name Modify Username Change Countersign

My Devices

Connect

Sound Settings

Live Stream

Help

Business relationship

V 2.12.ane.34.1

seven.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 listing to entries containing the alphanumerical digits entered. Selecting a patient displays a list of all recordings associated with the patient. Patients may exist added to the list individually through transmission input or syncing with compatible EHR services.

P. 17
Search Patient List Patient List Hospital ID
Add New Patient

7.6 Review Screen
This screen displays a waveform of each recording, options to playback the sound, or add together notes. Notes may be added by any user with access to the patient's profile.

P. eighteen Patient Information Recording Data
Playback

8.1 Electrical Safety

Guidance and Manufacturer'south Proclamation – 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 i

DUO uses RF energy simply for its internal function. Therefore, its RF emissions are very low and are non likely to cause whatsoever interference in nearby electronic equipment.

RF emissions CISPR 11
Harmonic Emissions IEC 6100-3-ii

Class B Not Applicative

DUO is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations/flicker emissions IEC 61000-3-three

Not Applicative

P. 19
Alarm: The use of accessories other than those specified, with the exception of accessories sold by Eko as replacement parts, may consequence in increased emissions or decreased amnesty of DUO.
Warning: DUO should not be used adjacent to or stacked with other equipment. If next or stacked use is necessary, DUO should be observed to verify normal operation in the configuration in which it will be used.

8.1

Electric Prophylactic

Guidance and Manufacturer'southward Annunciation – Electromagnetic Immunity

DUO is intended for employ 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 Surround-Guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

+/- 8 kV contact +/- 15 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with constructed material, the relative humidity should be at least 30%

Electrical Fast Transient/ Burst IEC 61000-4-4

+/- two kV for supply lines +/- 1kV for input/output lines

Mains power quality should exist that of a typical commercial or hospital environs

Surge IEC 61000-4-5

+/- 1 kV line to line +/- 2 kV line to earth

+/- 1 kV line to line +/- 2 kV line to globe

Mains power quality should be that of a typical commercial or hospital environment

Voltage dips, short

5% UT (95% dip in UT) for 0.5 cycles

interruptions and voltage 40% UT (60% dip in UT) for 5 cycles

variations on ability supply seventy% UT (30% dip in UT) for 25 bike

input lines

<5% UT (>95% dip in UT) for v sec

IEC 61000-4-xi

5% UT (95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for five cycles 70% UT (30% dip in UT) for 25 wheel <v% UT (>95% dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or infirmary environs.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-eight

xxx A/chiliad

30 A/yard

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-vi
Radiated RF IEC 61000-4-iii

3 Vrms 150kHz – 80 Mhz
iii Five/m 80 MHz to 2.5 GHz

iii Vrms 150kHz – 80 Mhz
iii 5/m 80 Mhz to 2.v Ghz

Portable and mobile RF communications equipment should be used no closer to whatsoever office of DUO, including cables, than the recommended separation altitude calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = [ three.5 / V1] P d = [ 3.5 / E1] P ninety MHz to 800 MHz d = [ 7 / E1] P 800 Mhz to 2.five 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 altitude 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:

Notation one – At 80 MHz and 800 MHz, the higher frequency range applies Annotation 2 – These guidelines may not utilise in all situations. Electromagnetic propagation is affected past absorption and is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such every bit base of operations stations for radio (cellular/cordless) telephones and state mobile radios, amateur radio, AM and FM radio circulate and TV broadcast cannot exist 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 functioning is observed, additional measures may be necessary, such every bit re-orienting or relocating DUO. b Over the frequency range 150 kHz to lxxx MHz, field strengths should exist less than iii Five/m.

8.1

Electrical Safe

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 aid prevent electromagnetic interference by maintaining a minimum distance betwixt 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 Co-ordinate to Frequency of Transmitter (m)

150 kHz to 80 MHz d = 1.2 P

80 MHz to 800 MHz d = 1.two P

800 MHz to two.5 GHz d = 2.3 P

0.01

0.12

0.23

0.1

0.37

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For transmitters rated at a maximum output power non 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 ability rating of the transmitter in watts (Due west) co-ordinate to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the college frequency range applies.
NOTE ii: These guidelines may non apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

ix.1

Manufacturing and Regulatory Information

Manufactured by: Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612 USA www.ekohealth.com

0537 Notified Body: Eurofins Expert Services Oy Notified Body No. 0537
EC REP
EC Authorized Representative: Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands

www.ekohealth.com
© 2020 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.
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