02/08/2018 Electronic Stethoscope System For Eko CORE Digital Attachment and Eko BUNDLE Electronic Stethoscope Model E4
02/08/2018 Contents Introduction, Warnings, & Safety Contact Information Installation 4 4 11 Core Use 12 Cleaning 14 Warranty Operating Conditions Core Modes and LED States Eko App Use 14 14 15 16 Bluetooth 16 Setting up PIN Capturing Recordings Adding Notes Sharing Patients App Diagrams 17 18 19 19 20 Electrical Safety 30 2
02/08/2018 1.1 Introduction, Warnings, and Safety The Eko Electronic Stethoscope System (herein referred to as Eko) is designed to support healthcare professionals 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).
02/08/2018 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. This product and packaging does not contain natural rubber latex. LATEX This product contains an intentional RF radiator certified by the FCC.
02/08/2018 CAUTION: • To reduce the risk of device interference, keep the Eko Core at least 1 meter away from all RF emitters including Wifi routers and radios. • 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. • To reduce the risks associated with inaccurate data acquisition store and operate this stethoscope only as instructed in this manual.
02/08/2018 NOTICE: and cause interference, immediately move Core 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 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.
02/08/2018 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 decision support in clinical settings. Eko is intended for use on pediatric and adult patients. It can electronically amplify, filter, and transfer sounds to the accompanying mobile application for storage and sharing.
02/08/2018 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. 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.
02/08/2018 1.9 Contents and Operation The Core package includes (1) Eko 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 Internet capabilities (not included). The compatible hardware and software platforms are listed below.
02/08/2018 2.1 Installation to Existing Stethoscopes Not applicable to Eko Bundle 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 & 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.
02/08/2018 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. To get the best sound, we recommend you test all Eko-supplied tubing adapters & select the one that provides the tightest fit with your analog stethoscope. Fig. 5 Core with Attached Tubing Fig. 6 Completed Installation 2.
02/08/2018 Test the Volume Level The Core’s sound level can be amplified in 7 increments up to 40X amplification of an acoustic stethoscope. Change the volume level by clicking the plus (+) 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 > Bluetooth > and tap the slider to turn Bluetooth ON. Then, navigate to the Menu screen by clicking on the top left tab in the App.
02/08/2018 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.
02/08/2018 4.1 Warranty Eko provides a limited warranty for Core Model E4. Please visit ekodevices.com/warranty for a full description of the warranty.
02/08/2018 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.
02/08/2018 On (quick blink) Playback The Core is ON and playing back sounds from a paired phone/tablet. On Volume Change 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 Low Battery The Core is ON and its battery level is below 25%. On Battery Expired The Core is ON and its battery level is below 10%. The Core will no longer stream or playback audio.
02/08/2018 7.1 Eko App Use Installation for iPhone 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 has finished installing. Installation for iPad Open the iTunes App Store using a supported iPad model. Ensure that the device is connected to the internet.
02/08/2018 Setting up a PIN Create a secure 4-digit PIN by logging in to the mobile application. Navigate to the Menu screen by selecting the icon on the top left of the Moblie App home screen. Next, select Account Settings > Create Pin. Follow the instructions on the screen to create and save a 4 -digit PIN. You will need to enter your PIN twice for verification purposes.
02/08/2018 Capture & Save Recordings using the Mobile App Open the Eko Mobile App and log in. Ensure that the Eko Core Device is paired to the mobile device (See Section 7.1). In the home screen, select the posture and position using the drop down lists at the top of the screen. Press the blue circular button to begin recording. Press the blue square button (in the same location as start button) to stop and save the recording. © 2017 Eko Devices, Inc.
02/08/2018 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. On the bottom of the recording screen, select the Notes icon. The Notes icon is a post-it symbol with writing on it. Select “Add Note” and begin typing your note. Select the the check mark to save.
02/08/2018 7.2 Main Recording Screen The Main Recording Screen allows users to view audio data captured by Core, begin the recording process, retrieve patientspecific data, or adjust settings. Audio data is represented in real-time as a phonocardiogram. A time-indicator above the waveform denotes 1/2 and 1-second intervals.
02/08/2018 Patient Selection Create a patient-specific recordings Review patient Records Import patients from select EHR systems Recording Setup Select patient position and posture 22
02/08/2018 7.3 Settings Screen The Settings icon on the Main Recording Screen will access Bluetooth pairing to the Core, view the remaining battery charge level of a connected Core, change playback volume, and playback method. 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. Setting a PIN is recommended so that users do not have to enter full login information each time the app is opened.
02/08/2018 Return to Previous Screen 24
02/08/2018 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.
02/08/2018 Return to Previous Screen Add New Patient Sync with selected EHR systems 26 Search Patient List
02/08/2018 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 Patient Actions Edit patient information, share patient, and delete patient account © 2017 Eko Devices, Inc.
02/08/2018 Patient Actions Edit Patient Name & ID Share Patient Delete Patient 28
02/08/2018 7.6 Review Screen More information on a specific recording can be viewed by tapping on a 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 Date and Time Position and Posture Time Signature (10 Seconds) Modify Recording Playback, delete, or add a note to the recording © 2017 Eko Devices, Inc.
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02/08/2018 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.
02/08/2018 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.
02/08/2018 Immunity Test Power frequency (50/60 Hz) magnetic field IEC 610004-8 IEC 60601 Test Level Compliance Level Electromagnetic Environment-Guidance 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial magnetic field or hospital environment. NOTE UT is the a.c.
02/08/2018 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.
02/08/2018 9.1 Manufacturing & Regulatory Information Manufactured by: Eko Devices, Inc. 2600 10th Street, Suite #260 Berkeley, CA 94710 USA 0537 Notified Body: VTT Expert Services Ltd. Kemistintie 3, Otaniemi, 02150 Espoo, Finland (Notified Body No. 0537). EC REP EC Authorized Representative: Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands Australian Sponsor: Emergo Australia Level 20 Tower II, Darling Park 201 Sussex Street Sydney, NSW 2000 Australia www.ekodevices.
