Instructions for Use (IFU) for KardiaMobile® (Model AC-019) 19LB01.X13 AliveCor, Inc. 444 Castro Street, Mountain View, CA 94041, USA © AliveCor, Inc. 2019 AliveCor is a registered trademark of AliveCor, Inc.
Instructions for Use for KardiaMobile® (Model AC-019) Table of Contents Introduction 3 Guide to Parts 3 Warnings 4 Cautions 5 Indications For Use 5 Terms 5 Setting up your KardiaMobile® (Model AC-019) hardware for the first time 6 Recording a Six-Lead ECG 8 Recording a Single-Lead ECG 10 ECG Analysis 12 Heart Rate 13 Previously Recorded ECGs 13 Clinical Testing 14 Environmental Specifications 14 Expected Service Life 14 Maintenance 15 Electromagnetic & Other Interferences 1
Instructions for Use for KardiaMobile® (Model AC-019) KardiaMobile® (Model AC-019) Introduction 1. The KardiaMobile® (Model AC-019) System allows you to record a Six-Lead ECG and a Single-Lead ECG. a. It is recommended that you record a Six-Lead ECG (which provides more data to your cardiologist) when possible. 2. The KardiaMobile® (Model AC-019) hardware is used with a user-supplied compatible smartphone or tablet. 3. The KardiaMobile® (Model AC-019) System consists of: a.
Instructions for Use for KardiaMobile® (Model AC-019) Warnings 1. AliveCor does not guarantee that you are not experiencing an arrhythmia or other health conditions when labeling an ECG as normal. You should notify your physician for possible changes in your health.DO use this device to record heart rate and heart rhythm only. 2. DO NOT use to diagnose heart- related conditions. 3. DO NOT use to self-diagnose heart related conditions.
Instructions for Use for KardiaMobile® (Model AC-019) Cautions 1. Detection of possible Atrial Fibrillation (AF) in your EKG results are not to be used for diagnosis. If you are experiencing any concerning symptoms, contact your physician. 2. Result of "Bradycardia" or "Tachycardia" are designations of heart rate, not a clinical diagnosis of an arrhythmia. Please consult with your physician should you receive consistent identifications of "Bradycardia" or "Tachycardia". 3.
Instructions for Use for KardiaMobile® (Model AC-019) Setting up your KardiaMobile® (Model AC-019) hardware for the first time 1. Remove KardiaMobile® (Model AC-019) from packaging. 2. Setup KardiaMobile® (Model AC-019) ○ Download the Kardia app from the App Store or Google Play on your compatible iOS or Android device (check for compatibility at www.alivecor.com/compatibility). ○ Make sure you have Bluetooth turned on your smartphone (or tablet). 3.
Instructions for Use for KardiaMobile® (Model AC-019) 6. Tap lightly on the 2 top electrodes (Left Hand Electrode and Right Hand Electrode) for 5 seconds to wake up your KardiaMobile® (Model AC-019) hardware and initialize Bluetooth pairing. 7. Select Pair to pair the KardiaMobile® (Model AC-019 hardware with your phone via Bluetooth.
Instructions for Use for KardiaMobile® (Model AC-019) Recording a Six-Lead ECG 1. Select Six-Lead on the Record ECG screen. NOTE: The Six-Lead option will be the default because it is recommended that you record a Six-Lead ECG (which provides more data to your cardiologist) when possible. If you prefer to record a Single-Lead ECG, follow the instructions in the section Recording a Single-Lead ECG. 2.
Instructions for Use for KardiaMobile® (Model AC-019) 3. Make sure that the AliveCor logo is in the correct orientation. 4. An ECG recording will take 30 seconds and will start once all three electrodes (Left Hand Electrode, Right Hand Electrode, and Left Leg Electrode) have good skin contact. NOTE: Good Contact will be indicated by green lights on the electrode diagram on-screen. An ECG recording will not start or will terminate when good skin contact is not obtained.
Instructions for Use for KardiaMobile® (Model AC-019) Recording a Single-Lead ECG NOTE: It is recommended that you record a Six-Lead ECG (which provides more data to your cardiologist) when possible. 1. Select Single-Lead on the Record ECG screen. NOTE: If you prefer to record a Six-Lead ECG, follow the instructions in the section Recording a Six-Lead ECG. 2. Rest your arms on a flat surface.
Instructions for Use for KardiaMobile® (Model AC-019) 3. Make sure that the AliveCor logo is in the correct orientation. 4. An ECG recording will take 30 seconds and will start once the Left Hand Electrode and Right Hand Electrode have good skin contact. Hold steady while you watch the countdown timer decrease from 30 to 0 seconds. ○ ○ NOTE: An ECG recording will not start or will terminate when good skin contact is not obtained.
Instructions for Use for KardiaMobile® (Model AC-019) ECG Analysis The KardiaMobile® (Model AC-019) hardware transmits the EKG signal from the electrodes to the Kardia app on a mobile computing platform to be analyzed and presented to the user. The KardiaMobile® (Model AC-019) System’s Kardia app will display an EKG, single-lead (Lead I only) or six-lead EKGs (Lead I, Lead II, Lead III, aVL, aVR and aVF) and EKG Analysis.
Instructions for Use for KardiaMobile® (Model AC-019) Unclassified Your EKG does not fall into the algorithmic classifications of Normal, Bradycardia, Tachycardia, or Atrial Fibrillation. This result may be caused by other physiological condition (for instance other arrhythmias, very fast or slow heart rates) or may be a result of poor quality recordings. This is not a diagnosis, only a possible finding. Contact a physician if you have questions or are concerned about any symptoms.
Instructions for Use for KardiaMobile® (Model AC-019) Clinical Testing The KardiaMobile® (Model AC-019) System was thoroughly evaluated in a clinical study to ensure users can get a medical grade ECG. Overall, 44 subjects participated in the study, that included patients with arrhythmias as well as normal subjects.
Instructions for Use for KardiaMobile® (Model AC-019) Maintenance 1. No service or repair should be performed on the KardiaMobile® (Model AC-019) hardware other than the maintenance listed in this section. 2. It is important to keep the electrodes clean by spraying with an alcohol-based sanitizer and wiping with a soft cloth when needed. ○ Do use a clean, lint-free cloth ○ DO NOT use abrasive cleaners or materials ○ DO NOT immerse device or expose device to excessive liquid 3.
Instructions for Use for KardiaMobile® (Model AC-019) CAUTION: Changes or modifications not expressly approved by AliveCor could void your authority to use this equipment. To view FCC information on the Kardia app: 1. On the home screen, tap to access Kardia app Settings. 2. Tap “About Kardia” to the FCC ID and other applicable regulatory information. Ingress Protection Marking KardiaMobile® (Model AC-019) is IP22 rated.
Instructions for Use for KardiaMobile® (Model AC-019) ○ ○ Option 5: If you wear hearing aids, turn them off prior to recording. Option 6: Avoid close proximity to items that may cause electrical interference (electronic equipment, computers, chargers, routers, etc.) 3. Problem: The ECG rhythm from Lead II does not appear while recording. Solution ○ Ensure that the bottom electrode (Left Leg Electrode) is touching the skin above your left knee or your left ankle.
Instructions for Use for KardiaMobile® (Model AC-019) Electrical Safety Guidance and manufacturer's declaration - electromagnetic emissions KardiaMobile® (Model AC-019) is intended for use in the electromagnetic environment specified below. The customer or the user of KardiaMobile® (Model AC-019) should assure that it is used in such an environment.
Instructions for Use for KardiaMobile® (Model AC-019) Guidance and manufacturer’s declaration—electromagnetic immunity KardiaMobile® (Model AC-019) is intended for use in the electromagnetic environment specified below. The customer or the user of KardiaMobile® (Model AC-019) should assure that it is used in such an environment.
Instructions for Use for KardiaMobile® (Model AC-019) Guidance and manufacturer’s declaration—electromagnetic immunity KardiaMobile® (Model AC-019) is intended for use in the electromagnetic environment specified below. The customer or the user of KardiaMobile® (Model AC-019) should assure that it is used in such an environment.
Instructions for Use for KardiaMobile® (Model AC-019) b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Instructions for Use for KardiaMobile® (Model AC-019) Recommended separation distances between portable and mobile RF communications equipment and KardiaMobile® (Model AC019) KardiaMobile® (Model AC-019) is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Instructions for Use for KardiaMobile® (Model AC-019) Equipment Symbols These symbols will be used in the packaging and other labeling of the KardiaMobile® (Model AC-019) hardware.
