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Table of Contents
Related Manuals for EKO DUO
Summary of Contents for EKO DUO
- Page 1 User Manual...
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Page 2: Table Of Contents
The Eko DUO System is designed to support 1.1 Indications for Use ............pg 2 The Eko DUO System is intended to be used by healthcare professionals in analyzing cardiac and healthcare professionals to electronically amplify, 1.2 Introduction, Warnings and Safety ....pg 2... -
Page 3: For Help And Assistance
Eko Devices, Instructions for use. Wireless Bluetooth communication Inc. directly Please report any injury or adverse event to Eko using Do not dispose with household waste To identify a type CF applied part complying any of the contact methods below. -
Page 4: Caution
• DUO contains a Bluetooth Class 2 wireless • This device does not detect or measure all heart DUO at least 2 meters away from all RF emitters data link. The maximum radio frequency field rate, heart rhythm and heart waveform changes. -
Page 5: Skin Preparation
Operation is subject to two conditions: (1) This device IC: 23063-DUO tracing. Do not use DUO over wound areas or may not cause harmful interference, and (2) this MIC ID: 020-210076 areas of broken skin. -
Page 6: Cleaning
In order to transmit sounds and record electrical the electrodes with an alcohol-based cleaning medical professionals. The device may be used on activity to Eko App, DUO and the mobile device must solution prior to use. patients during a physical assessment in a clinical... -
Page 7: Patient Privacy
NOTE: DUO can be used with other audio equipment proceed to collect or save such information. or headphones through the 3.5mm audio jack. -
Page 8: Setup
2.2 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 tightening the threads. -
Page 9: T Urning On And Off, Changing Filters, Taking A Recording
DUO - User Manual Pg 9 3.1 Turning On and Off, Changing Filters, and Taking a Recording DUO is controlled using the center/action button located on the top face. An LED ring illuminates when the device is powered on. Button Do This LED Ring Response Pushes Center/Action Button Volume Button –... -
Page 10: Led Indicator Lights
DUO - User Manual Pg 10 3.2 LED Indicator Lights The device is ON and has low The device is OFF. All battery. The orange warning functions of the device are LED turns on. Device functions disabled. normally. The device is ON but not The device is ON and its paired. -
Page 11: Capturing Sounds And Ecgs
DUO - User Manual Pg 11 3.3 Capturing Sounds and ECGs To capture sounds and ECGs, DUO can be used on various locations and orientations of the chest. Each position will produce a unique heart sound and ECG tracing. Audio... -
Page 12: Operating Conditions
DUO - User Manual Pg 12 4.1 Operating Conditions Environmental The operating range of DUO is 10° to 45°C (50 to 113°F), and 10% to 95% relative humidity. The storage and transport range is -10° to 60° C and 10% to 95% relative humidity. -
Page 13: Eko App Use
DUO - User Manual Pg 13 5.1 Eko App Use Eko App helps you easily connect to DUO for secure transmission and analysis of your recordings. Downloading Eko App allows you to: • Pair DUO to your phone • Listen wirelessly •... -
Page 14: Electrical Safety
Eko as replacement parts, may result in increased emissions or decreased immunity of DUO. 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. Warning: DUO should not be used adjacent to or stacked with other equipment. - Page 15 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 DUO is used exceeds the applicable RF compliance level above, DUO should be observed to verify normal operation.
- Page 16 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.
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Page 17: Manufacturing And Regulatory Info
DUO - User Manual Pg 17 7. 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 Authorized Representative: Emergo Europe... - Page 18 ©2021 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 215 Rev A — August, 2021...