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Eko Devices DUO E5 User Manual

Designed to support healthcare professionals in analyzing cardiac and other internal organ sounds
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User Manual, Model E5

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Summary of Contents for Eko Devices DUO E5

  • Page 1 User Manual, Model E5...
  • Page 2 For general and product related comments, questions, Consult instructions for use. healthcare professionals in analyzing cardiac and or concerns, please contact Eko Devices, Inc. directly other internal organ sounds. The Eko Model E5 This product contains electrical and System includes a device capturing heart sounds...
  • Page 3 Caution CAUTION • • To reduce the risk of device interference, keep DUO contains a Bluetooth Class 2 wireless rate, heart rhythm and heart waveform changes. DUO at least 2 meters away from all RF emitters data link. The maximum radio frequency field •...
  • Page 4 Skin Preparation EMC Compliance Cleaning Excessive hair, dirty skin, dry skin, or oily skin can FCC Intentional Radiator Certification To ensure a proper ECG and PCG recording, clean the impact the quality of the ECG tracing. Clean the electrodes with an alcohol-based cleaning solution patient's skin with water and soap and remove excess Contains FCC ID: XXXXXXXXXX prior to use.
  • Page 5 Precautions The device is intended to be prescribed by licensed The device uses a Bluetooth Class 2 wireless data medical professionals. The device may be used on link. The Bluetooth range will be reduced when patients during a physical assessment in a clinical objects (walls, furniture, people, etc) are between DUO setting or by patients with a prescription and under the and a paired mobile device.
  • Page 6 1.10 1.11 Indications for Use Patient Privacy Contents and Operation The Eko Model E5 System is intended to be used by The privacy of patient health information may be This package includes healthcare professionals to electronically amplify, protected by state, federal, or international/foreign (1) Eko DUO filter, and transfer body sounds and single-channel laws that regulate how such information can be used,...
  • Page 7 Setup Charging Install included EARPIECE by plugging the audio jack To charge DUO, place the device on the Wireless into the 3.5mm audio port at the base of DUO and Touch Charging Pad. Connect the charging pad to a tightening the threads. power source using the included USB charging cable and power adapter.
  • Page 8 DUO Use DUO is controlled using the action button located on the top face. An LED ring illuminates when the device is powered on. Do This LED Ring Response Power On / Off Press and hold the action The active LED turns on/off button for two seconds.
  • Page 9 DUO Use The device is OFF. All functions The device is ON and has low of the device are disabled. battery. The red warning LED turns on. Device functions normally. The device is ON and its The device is ON but not paired.
  • Page 10 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. Capture sounds by placing DUO anywhere on the body. For best audio, press the device firmly against Electrodes Diaphragm the skin to ensure good contact.
  • Page 11 Operating Conditions Warranty Environmental Eko provides a limited warranty for DUO. The operating range of the Core is 10° to 40°C (50 to Please visit ekodevices.com/warranty for a full 113°F), and 10% to 95% relative humidity. The storage description of the warranty. and transport range is -10°...
  • Page 12 Eko App Use Installation for iPhone® Log In with Username and Password Bluetooth Pairing Open the App Store® using a supported mobile device. Ensure Open the Eko App on the mobile device. When prompted, create a Bluetooth must be enabled in the smartphone or tablet’s Bluetooth that the device is connected to the internet and search for the Eko new account, or enter your existing username and password.
  • Page 13 Eko App Use Capture & Save Recordings using the Mobile App Adding Notes to Recordings on Mobile App Sharing from the Eko Mobile App Open the Eko Mobile App and log in. Ensure that DUO To create notes on any patient recordings, log into Patients and recordings can be shared to other is paired to the mobile device (See Bluetooth...
  • Page 14 Main Recording Screen The Main Recording Screen allows users to view audio data captured by the device, begin the recording Recording Setup process, retrieve patient-specific data, or adjust settings. Audio data is represented in real-time as a Select Position AT&T phonocardiogram and the ECG waveform.
  • Page 15 Settings Screen 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 filter modes. The Settings screen also allows users to change email and password information or My Devices Connect...
  • Page 16 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 list to entries containing the Add New Patient AT&T alphanumerical digits entered.
  • Page 17 Review Screen 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 profile. AT&T 1:45 PM Patient Information Crouch, Tyler Heart - Aortic Recording Data Comments NOTES...
  • Page 18 Electrical Safety Warning: The use of accessories other than those Guidance and Manufacturer’s Declaration - Electromagnetic Emission specified, with the exception of accessories sold by DUO is intended for use in the electromagnetic environment specified below. The user of DUO should assure that it is used Eko as replacement parts, may result in increased in such an environment.
  • Page 19 Electrical Safety Guidance and Manufacturer’s Declaration - Electromagnetic Immunity DUO is intended for use 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 Environment-Guidance Electrostatic Discharge...
  • Page 20 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.
  • Page 21 © 2016 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. LBL 009 B...