Electronic Stethoscope System For Eko CORE Digital Attachment and Eko Digital Stethoscope Model E6
Contents Introduction 3 Contact Information 3 Warnings & Safety 4 Indications for Use 8 Installation 11 CORE Use 12 Cleaning 14 Warranty 14 Operating Conditions CORE Modes and LED States Eko App Use 15 16 17 Electrical Safety 18 2
1.1 Introduction 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.
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.
CAUTION: • To reduce the risk of device interference, keep 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.
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. CORE 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 CORE. 1.
Canada regulatory statement(s): This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) This device may not cause interference; and (2) This device must accept any interference, including interference that may cause undesired operation of the device. Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio exempts de licence.
1.6 Indications for Use Eko Electronic Stethoscope System 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.
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 CORE and a paired mobile device.
1.9 Contents and Operation CORE includes (1) CORE, (2) stethoscope tubing adapters, and (1) micro USB cable. 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. The Bundle package includes (1) CORE fully assembled with an acoustic stethoscope, and (1) micro USB cable.
2.1 Installation to Existing Stethoscopes Not applicable to Eko Digital Stethoscope Step One Remove the existing chest piece and insert it into the compatible adapter tubing provided Step Two Insert the CORE Digital Attachment to the adapter tubing Step Three Attach the CORE Digital Attachment to your headset and you are ready to go © 2019 Eko Devices, Inc.
2.2 CORE Use Charge Battery The battery in 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 a UL-certified USB wall charger. The LED will turn solid yellow, signifying that it is charging. The LED will change to solid green when the device is fully charged. NOTE: CORE will not turn on while it is plugged in and charging. Power Off When CORE is turned Off, sounds will be heard as through the analog stethoscope.
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. Adding Notes to Recordings on Moblie 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.
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 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.
5.1 Operating Conditions Environmental The operating range of 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.
6.1 CORE Modes and Corresponding LED States.
7.1 Eko App Download the Eko app, available on the App Store® and Google Play and follow the on-screen instructions to connect to CORE. Bluetooth must be enabled in the mobile or desktop’s Bluetooth settings in order to use CORE with the Eko App. © 2019 Eko Devices, Inc.
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.
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 Power frequency (50/60 Hz) magnetic field IEC 610004-8 IEC 60601 Test Level Compliance Level Electromagnetic Environment-Guidance 30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial magnetic field or hospital environment. NOTE UT is the a.c.
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.
9.1 Manufacturing Information Manufactured by: Eko Devices, Inc. 2600 10th Street, Suite #260 Berkeley, CA 94710 USA www.ekohealth.com © 2019 Eko Devices, Inc.