Related Manuals for AliveCor KardiaMobile 6L
Summary of Contents for AliveCor KardiaMobile 6L
- Page 1 Instructions for Use (IFU) KardiaMobile 6L (AC-019) 19LB01.02 AliveCor, Inc. 444 Castro Street, Mountain View, CA 94041, USA © AliveCor, Inc. 2020 AliveCor is a registered trademark of AliveCor, Inc.
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Page 2: Table Of Contents
Introduction Guide to Parts Warnings Cautions Indications For Use Features & Functionality Setting up your KardiaMobile 6L hardware for the first time Recording a Single-Lead EKG Recording a Six-Lead EKG EKG Analysis Heart Rate Clinical Safety and Performance Environmental Specifications... -
Page 3: Introduction
KardiaMobile 6L Introduction 1. KardiaMobile 6L is a 3-electrode personal EKG device that records your EKG and wirelessly transmits the data to your smartphone or tablet. a. Contains two electrodes on the top surface, for use with the left and right hands, and one on the bottom surface, for use with the bare skin of the left leg. -
Page 4: Warnings
4. DO NOT continue use until further instructed by a physician if your skin is irritated or inflamed around the electrode. 5. AliveCor makes no warranty for any data or information that is collected erroneously by the device, or misuse or malfunction as a result of abuse, accidents, alteration, misuse, neglect, or failure to maintain the products as instructed. -
Page 5: Cautions
The device has not been tested and is not intended for pediatric use. Features & Functionality KardiaMobile 6L is a 3-electrode personal EKG device that is capable of recording two kinds of EKGs: a Single-Lead EKG and a Six-Lead EKG, which provides more data for you to share with... -
Page 6: Setting Up Your Kardiamobile 6L Hardware For The First Time
Both EKG types detect normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and indeterminate results (errors or unclassified rhythms). KardiaMobile 6L has two electrodes on the top surface and one on the bottom surface. It is powered by a replaceable battery, which is located under the bottom electrode. Bluetooth is used to wirelessly transmit EKG data from the device to your smartphone or tablet. -
Page 7: Recording A Single-Lead Ekg
Follow the instructions below to record a Single-Lead EKG. 1. Open the app and tap "Record your EKG". 2. If this is your first time using the KardiaMobile 6L, follow the on-screen instructions to set up and pair your device. - Page 8 There's no need to squeeze or press down firmly. o Make sure the device is in the correct orientation with the AliveCor "A" facing you. 5. With your thumbs resting on the top two electrodes, place the EKG device on the bare skin of your left leg (knee or inside of the ankle).
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Page 9: Ekg Analysis
Instructions for Use for KardiaMobile 6L EKG Analysis Upon completion of your EKG recording, KardiaMobile 6L transmits the EKG data to the Kardia mobile app. The EKG is then processed by AliveCor’s Instant Analysis algorithms. The app will display your full Single-Lead or Six-Lead EKG and the Instant Analysis result with description. -
Page 10: Heart Rate
EKG output as well as the enhanced filtered (EF) EKG output. KardiaMobile 6L EKGs had a minimum correlation of 0.96 and a maximum RMS error of 47 µV as compared to the corresponding lead of the 12-lead EKG. The results of the quantitative analysis of the EKG recordings further confirmed that the KardiaMobile 6L device EKG has equivalent output to that of the gold standard 12-lead EKG device. -
Page 11: Environmental Specifications
The expected service life for KardiaMobile 6L is 2 years. Maintenance 1. No service or repair should be performed on the KardiaMobile 6L hardware other than the maintenance listed in this section. 2. Clean the electrodes by wiping with a soft cloth dampened with water or one of the following... -
Page 12: Electromagnetic & Other Interferences
DO NOT replace the battery when device is in use. Electromagnetic & Other Interferences KardiaMobile 6L has been tested and deemed in conformance with the relevant requirements in IEC 60601-1 -2:2014 Class B for Electromagnetic Compatibility (EMC). FCC Compliance FCC ID: 2ASFFAC019 This device complies with Part 15 of the FCC Rules. -
Page 13: Ingress Protection Marking
(2) This device must accept any interference, including interference that may cause undesired operation of the device. Ingress Protection Marking KardiaMobile 6L is IP22 rated. KardiaMobile 6L is protected against insertion of fingers and is not affected by vertically dripping water. KardiaMobile 6L has been tested with relevant requirement standard IEC 60601-1-11:2015. - Page 14 "Record a Single-Lead EKG" or "Record a Six-Lead EKG." o If Bluetooth is on, try to un-pair and pair again to your KardiaMobile 6L. ○ If Bluetooth is on and your device is not connecting or pairing it’s possible that your battery needs to be replaced.
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Page 15: Electrical Safety
Electrical Safety Guidance and manufacturer's declaration - electromagnetic emissions KardiaMobile 6L is intended for use in the electromagnetic environment specified below. The customer or the user of KardiaMobile 6L should assure that it is used in such an environment. Emissions test... - Page 16 Instructions for Use for KardiaMobile 6L Guidance and manufacturer’s declaration—electromagnetic immunity KardiaMobile 6L is intended for use in the electromagnetic environment specified below. The customer or the user of KardiaMobile 6L should assure that it is used in such an environment.
- Page 17 Instructions for Use for KardiaMobile 6L Guidance and manufacturer’s declaration—electromagnetic immunity KardiaMobile 6L is intended for use in the electromagnetic environment specified below. The customer or the user of KardiaMobile 6L should assure that it is used in such an environment. Immunity IEC 60601...
- Page 18 Recommended separation distances between portable and mobile RF communications equipment and KardiaMobile 6L KardiaMobile 6L is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of KardiaMobile 6L can help prevent...
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Page 19: Equipment Symbols
Instructions for Use for KardiaMobile 6L Equipment Symbols These symbols will be used in the packaging and other labeling of the KardiaMobile 6L hardware. Type CF Applied Part Do not dispose with household waste Read instructions before use Manufacturer Temperature range...