Eko Core, Model 1 User Manual v. 001
Contents
1. please contact Eko Devices Inc directly Eko Devices Inc 2600 10th St Suite 260 Berkeley CA 94710 USA General Assistance and FAQs www ekodevices com support Direct Contact an support ekodevices com PHONE SUDDOIT rra 1 844 356 3384 Product Reference and Information www ekodevices com 2015 Eko Devices Inc 4 1 3 Safety Related Labels amp Symbols O bt E rn rn 93 15 Q Haw 30 C 104 F 22 F D gt AS 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 certified by the FCC Catalog Number Batch 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 1 4 Signal Word Consequences Indicates a hazardous situation which if A CAUTION not avoided could result in injury and or property damage and or damage to the device Indicates a hazardous situation which NM NOTICE if not avoided may result in property damage 5 AN CAUTION e To reduce the risk of device interference k2. U for 25 cycle lt 5 U gt 95 dip in U for 5 sec Not Applicable 29 Immunity IEC 60601 Compliance Electromagnetic Test Test Level Level Environment Guidance Power 3 A m 3 A m Power frequency frequency magnetic fields should 50 60 Hz be at levels characteristic magnetic of a typical location in field a typical commercial IEC 61000 4 8 magnetic field or hospital environment NOTE U is the a c mains voltage prior to application of the test level Guidance and Manufacturer s Declaration Electromagnetic Immunity The Eko Electronic Stethoscope System is intended for use in the electromagnetic environment specified below The user of the Eko Electronic Stethoscope System should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz Not Applicable Radiated RF IEC 61000 4 3 3V m 80 MHz to 2 5 GHZ 2015 Eko Devices Inc 3V m 80 MHz to 2 5 GHz 30 d 1 2 VP 80 MHz to 800 MHz d 2 3 4P 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 determined by an electromagnetic site survey should be less tha
3. 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 1 6 Indications for Use Eko is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic 7 decision support in clinical settings It consists of an electronic attachment for an analog stethoscope that samples sounds through a connected analog stethoscope It may be used for the detection and amplification of sounds from the heart and other internal organs including lungs arteries and veins There are no known contraindications for Eko although care should be taken when considering using the device according to the warnings and precautions below Eko is not life supporting or life sustaining 1 7 Precautions The device is intended to be prescribed by licensed medical professionals for use on patients during a physical assessment in a clinical setting The system provides one source of data that is significant only when used in conjunction with physician oversight and consideration of oth
4. Eko Eko Core Model 1 User Manual v 001 Contents Introduction Warnings amp Safety 4 Contact Information u u 4 Installation 11 COE USE seresa tee ee ener een 12 Cleaning ee 14 Warranty ieee 14 Operating Conditions 14 Core Modes and LED States 16 Eko App Use ceee 17 Electrical Safety anne 28 1 1 Introduction Warnings and Safety The Eko Electronic Stethoscope System herein referred to as Eko is designed to support healthcare professional in analyzing cardiac and other internal organ sounds Eko includes a device that is attached to a stethoscope Core a smartphone application App and a web application Dashboard Core features sound amplification and audio transmission to a smartphone via Bluetooth that allows the user to open and playback sounds in a mobile application on compatible iOS smartphones and tablets The app provides the ability to save sounds within Electronic Health Records EHR systems share patient records with other practitioners and annotate notes on recorded audio Eko is intended for use on pediatric and adult patients CAUTION Federal USA law restricts this device to sale by or on the order of a clinician 1 2 For Help and Assistance Please report any injury or adverse event to Eko Devices using any of the contact methods below For general and product related comments questions or concerns
5. and minus volume buttons on the side of the Core Bluetooth Pairing First enable Bluetooth on the selected mobile device On the iOS device go to Settings gt Bluetooth gt and tap the slider to turn Bluetooth on If the mobile device does not begin scanning right away check the Bluetooth Connection screen in the App s settings menu to enable scanning The mobile device is now ready to record sounds from the Core If Bluetooth pairing is unsuccessful an error message will appear in the App and no sounds will be recorded If the Bluetooth connection is successful the LED will turn from flashing blue to green See Section 2 3 for the LED states of the device 3 1 Cleaning Cleaning and Disinfecting Procedure The stethoscope and Core should be cleaned between each patient use All cleaning instructions pertaining to the original stethoscope apply Under normal conditions it is unnecessary to remove the Core from the stethoscope tubing 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 If it becomes necessary to remove the Core pull the stethoscope tubing off of the metal stem on both ends of the device Wipe all parts of the stethoscope clean with 70 isopropyl alcohol wipes including the Core s surface stethoscope tubing tubing connector and chest piece Reasse
6. e retained for future reference e To reduce the risk associated with an electrical shock do not use the stethoscope on patients without the analog stethoscope s chest piece in place e Core Model 1 contains a Bluetooth Class 2 wireless data link The maximum radio frequency field strength generated by the stethoscope 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 2015 Eko Devices Inc 6 AN NOTICE and cause interference immediately move Core away from that device and or turn the Bluetooth feature OFF e To reduce the risks associated with environmental contamination follow applicable regulations when disposing of this stethoscope The Eko Core stethoscope attachment contains a lithium ion polymer 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 the Eko Core 1 5 EMC Compliance FCC Intentional Radiator Certification Contains FCC ID QOQBLE113 Contains IC 5123A BGTBLE113 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
7. eep the Eko Core at least 1 meter away from all RF emitters including Wifi routers and radios e 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 e To reduce the risks associated with inaccurate data acquisition store and operate this stethoscope only as instructed in this manual Though there is an acoustic non amplified mode available with this stethoscope it is highly recommended that the battery be recharged within thirty minutes of the LED indicator turning red Recharge the battery using only the USB power cord and charger provided with the device DO NOT immerse the stethoscope in a liquid or subject it to any sterilization processes other than those described in this manual e To reduce the risks associated with very strong electromagnetic fields avoid using the stethoscope 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 Devices may result in increased RF emissions or decreased immunity of the Eko Electronic Stethoscope System e Please read understand and follow all safety information contained in these instructions prior to using the Eko Electronic Stethoscope System It is recommended that these instructions b
8. er relevant patient information Eko should be used only by qualified clinicians Eko is intended for use on patients that can be auscultated on normally with an acoustic stethoscope This manual provides instructions for the use of Core and Eko web and mobile applications It is assumed that the user is familiar with basic website navigation and mobile application use on iOS devices This device is only indicated for use in a hospital physician s office or other clinical setting Standard procedures for auscultation should be followed including background noise reduction and optimal patient positioning In order to transmit sounds to the Eko App the stethoscope and device must be connected via Bluetooth and in order to fully use certain functions the mobile device must be connected to the internet via cellular data connection or Wi Fi 2015 Eko Devices Inc 8 Core uses a Bluetooth Class 2 wireless data link The Bluetooth range will be reduced when objects walls furniture people etc are between the Core and a paired mobile device To improve Bluetooth connection reduce the distance and or allow a line of sight between the Core and mobile device It is highly recommended that users of the Eko Dashboard and Eko App 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 Please consult your institution s technica
9. et capabilities not included The compatible hardware and software platforms are listed below Compatible Stethoscopes Eko is designed and tested to work with the 3M Littmann Cardiology Il and Cardiology Ill lines of analog stethoscopes Eko will work with many other stethoscope brands and models but no performance guarantees are claimed using other models or brands NOTE Core 1 is not compatible with any digital stethoscopes System Requirements The mobile app software can be used on iPhone 4S iPhone 5 5C 5S iPhone 6 6 iPad Mini 2 3 iPad Air Air 2 and iPad 3rd and 4th generations with iOS 6 1 and greater and 25MB of free memory Core 1 uses Bluetooth 4 0 LE mobile devices used must be compatible with Bluetooth 4 0 Littmann 3M and Cardiology Ill are registered trademarks of the 3M Corporation iPhone iPad iTunes and iOS are registered trademarks of Apple Inc Bluetooth is a registered trademark of Bluetooth SIG Inc 2015 Eko Devices Inc 10 2 1 Installation Detach Chest Piece Remove chest piece of the analog stethoscope manually Grip the chest piece with one hand and the tubing in the other then twist and pull them apart This may require some force See Fig 1 amp 2 Fig 1 Detach the Chest Piece Fig 2 Detached Chest Piece Install Eko Core Insert the narrow end of the Core into the tubing of the stethoscope The metal stem fits into the hollow opening of the tube NOTE Ensure the
10. ia Bluetooth The Core is ON and paired with a phone tablet The Core will stream live audio from the stethoscope chest piece to the paired device The Core is ON and playing back sounds from a paired phone tablet The Core is ON and changing playback volume based on commands from the volume buttons or paired phone tablet The LED will blink once for each volume interval changed On The Core is ON and its battery Low Battery level is below 25 si P On The Core is ON and its battery Battery Expired level is below 10 The Core will no longer stream or playback audio y 8 off The Core is OFF and connected Charging to a power source The battery is charging Off The Core is OFF and connected Fully Charged to a power source The battery is fully charged 100 7 1 Eko App Use Installation Open the iTunes App Store using a supported mobile device Ensure that the device is connected to the internet and search for the Eko App Follow the instructions to download the Eko App and wait until it is finished installing Logging In Open the Eko App on the mobile device When prompted create a new account or enter your existing username and password Turn On Bluetooth Bluetooth must be enabled in the smartphone or tablet s Bluetooth settings in order to use Core with the Eko App Follow the instructions in 2 2 Core Use and connect to the Core 7 2 Main Recording Screen The Main Recording Screen allow
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12. l services to implement appropriate security measures 1 8 Patient Privacy 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 identifiable health information in order to function Records are stored and recalled through the use of patient name and date of birth By entering this information the user assumes any and all risks of and liabilities incurred with using or transmitting such information 1 9 Contents and Operation This package include 1 Core 2 stethoscope tubing adapters 1 micro USB cable and 1 USB charger This device is non assembled and must be installed by the user For full functionality the system requires an acoustic stethoscope and smart mobile device with wireless Intern
13. mble the stethoscope by reinserting the metal stems into the stethoscope tubing as before 4 1 Warranty Eko provides a limited warranty for Core Model 1 Please visit ekodevices com warranty for a full description of the warranty 5 1 Operating Conditions Environmental The operating range of the Core is 30 to 40 C 22 to 104 F and 15 to 93 relative humidity The storage and transport range is 40 to 55 C 40 to 131 F and 15 to 93 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 2015 Eko Devices Inc 14 Operating Warnings Failure to follow care and maintenance recommendations could result in damage to the internal components of the Core Internal damage to the product could cause malfunction of the product possibly leading to complete loss of function If problems are encountered with the Core do not attempt to repair it Please notify our support team for assistance 6 1 Eko Core Modes and Corresponding LED States O of O On Not Paired On Paired N J E A O On quick blink Playback i On Volume Change 2015 Eko Devices Inc The Core is OFF Sounds from the stethoscope pass through unfiltered The Core is ON but not paired The Core is discoverable and ready to connect v
14. n the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Np 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 a 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 the Eko Electronic Stethoscope System is used exceeds the applicable RF compliance level above the Eko Electronic Stethoscope System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Eko Electronic Stethoscope System gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Eko Electronic Stethoscope System The Eko Electronic Stethoscope System is intended for use in the electromagnetic e
15. nvironment in which radiated RF disturbances are controlled The user of the Eko Electronic Stethoscope System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Eko Electronic Stethoscope System as recommended below according to the maximum output power of the communications equipment Rated Maximum Output Power of Transmitter W Transmitter m Separation Distance According to Frequency of 150 kHz to 80 80 MHz to 800 800 MHz to MHz MHz 2 5 GHz d 1 2 P d 1 2 4P d 2 3 4P 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 reflection from structures objects and people www ekodevices com 2015 Eko Devices Inc All Rights Reserved Eko the Eko logo and Core are trademarks of Eko Other company and product names may be trademar
16. onic Stethoscope System Warning The Eko Electronic Stethoscope System should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the Eko Electronic Stethoscope System should be observed to verify normal operation in the configuration in which it will be used 2015 Eko Devices Inc 28 Guidance and Manufacturer s Declaration Electromagnetic Immunity The Eko Electronic Stethoscope System is intended for use in the electromagnetic environment specified below The user of the Eko Electronic Stethoscope System 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 6 kV contact 8 kV 6 kV contact 8 KV air Floors should be wood concrete or ceramic tile Iffloors are covered with synthetic material the relative humidity should be at least 30 Electrical Fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 2 kV for supply lines 1 kV for input output lines 1kV line s to line s 2 kV line s to earth Not Applicable Not Applicable Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycle 70 U 30 dip in
17. re 10 Seconds 2015 Eko Devices Inc 26 Appleseed John a May 16 2014 9 30AM e on onocofboonooooo o Tricuspid Standing Playback Pause Notes Delete Recording 27 8 1 Electrical Safety Guidance and Manufacturer s Declaration Electromagnetic Emission The Eko Electronic Stethoscope System is intended for use in the electromagnetic environment specified below The user of the Eko Electronic Stethoscope System should assure that it is used in such an environment Applicable Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The Eko Electronic Stethoscope System 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 RF emissions CISPR 11 Class B Harmonic Emissions IEC 6100 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Not Applicable Not Applicable The Eko Electronic Stethoscope System 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 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 the Eko Electr
18. s 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 Eko App from this screen Hardware AO EDESA ere eC ee ee OC RCAC Rare a Modify Bluetooth Connection Adjust Volume Settings 1 7 Change Audio Source iPhone speakers or Stethoscope Earpieces Support RETTET TER OUT Wome E aR RD ISG we Race Arde Help Link to www ekodevices com support Account Bee ee ARA IA Sew Re ALEA AA Sie Modify Name Modify Username Modify Password and PIN Update Contact Information Log Out 2015 Eko Devices Inc 20 Return to Previous Screen ernennen nennen ne a December 13 2015 HARDWARE Bluetooth Volume Audio Source SUPPORT ACCOUNT a Account Settings 7 4 Patients Screen Selecting the Patient Search icon on the main screen brings up the patient list and search bar The list of patients appears in alphabetical order The search bar narrows the list to entries containing the alphanumerical digits entered Selecting a patient will display 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 Patient Name Alphabetical nenne Hospital ID Shared Patient Indicator EA LEE E A NEE EEE ER ae Indicates patients shared by another Eko user 2015 Eko Devices Inc 22 Returnto Add Sync with Previous New selected EHR Screen Patient sy
19. s users to view audio data captured by Core begin the recording process retrieve patient specific data or adjust settings Audio data is represented in real time as a phonocardiogram A time indicator above the waveform denotes 1 20 1 2 and 1 second intervals Fig A Unpinned Recording No Patient Assigned Fig B Pinned Recording Patient Assigned Settings een nennen seen Modify Bluetooth Connection Adjust Volume Change Audio Source iPhone speakers or Stethoscope Earpieces Adjust Account Details Name Username Password PIN Contact Information Audio Waveform ER EN RE ARA EN IE TE RENNEN Retrieved from the Core Setup Recording Dee Select position and posture before making a recording 2015 Eko Devices Inc 18 Patient Selection lt cccccccc crete E Create a patient specific recordings Review patient Records Import patients from select EHR systems 9 41 AM No Patient Selected 9 41 AM Appleseed Jo Tricuspid Star e ole May 16 2014 9 30 7 3 Settings Screen The Settings icon on the Main Recording Screen will access connection or disconnection to the Core view the remaining battery charge level of a connected Core and change playback volume The Settings screen will also allow users to change email and password information or set a login PIN The PIN allows for quicker access to the Eko App if the user has exited the app but has not closed it Setting a PIN i
20. smaller end of the Core is connected to the stethoscope tubing See Fig 3 amp 4 Fig 3 Connector and Chest Piece Fig 4 Left Core on Stethoscope Tubing Right Connector on Chest Piece Reattach Tubing and Chest Piece Attach the additional tubing connector onto the end of the Core as shown below Then attach the chest piece into the tubing connector as it was on the analog stethoscope NOTE Ensure that the wide end of the Core is oriented towards the head of the stethoscope Fig 5 Core with Attached Tubing Fig 6 Completed Installation 2 2 Core Use Charge Battery The battery in the Core will need to be charged insert the included micro USB cable into the USB port on the device and plug the other end into the included USB charger The LED will begin to flash yellow signifying that it is charging The LED will change to solid yellow when the device is fully charged NOTE Core will not turn on while it is plugged in and charging Power Off When the Core is turned Off sounds will be heard as through the analog stethoscope Power On Press the circular slider button on the side of the Core in to power it On The LED will turn on when the device is powered On When the Core is On sounds will be amplified 2015 Eko Devices Inc 12 Test the Volume Level The Core s sound level can be amplified in 7 increments up to 20X amplification of an acoustic stethoscope Change the volume level by clicking the plus
21. stems o EHR Sync A Eu EE Appleseed John XSS97849604 Craig Jaime TGZ638759D5 Cummings Sally LMF578528M6 Hill Andrea VQJ753787P8 Aaker Martin XDY35227207 Anthony John TFT59848607 23 Search Patient List e em Search 7 5 Profile Screen Access patient information on the Patient Profile page From this page users may access previously assigned recordings or add a new recording to the patient s record history The Patient Actions icon in the lower navigation bar enables editing and sharing of patient information Recording List dae Add New Recording li 2015 Eko Devices Inc 24 Patient Actions Edit Patient Name amp ID Share Patient Delete Patient Appleseed John X55597849604 b Dec 12 2014 All Recordings 7 May 20 2014 9 25 AM Tricuspid Standing May 20 2014 9 20 AM Mitral Standing Apr 04 2014 4 17 PM Mitral Sitting Nov 16 2013 11 13 AM Aortic Standing Nov 16 2013 11 10 AM Pulmonic Standing 25 7 6 Review Screen More information on a specific recording can be viewed by tapping ona recording listing This screen displays a waveform of the recording options to playback the sound and notes Notes may be added by any user with access to the patient s profile Recording Data re ne eee eae eae see nee Date and Time Position and Posture Time Signatu
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