Related Manuals for AliveCor KardiaMobile AC-019
Summary of Contents for AliveCor KardiaMobile AC-019
- Page 1 Instructions for Use (IFU) 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.
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Page 2: Table Of Contents
Instructions for Use for KardiaMobile® (Model AC-019) Table of Contents Introduction Guide to Parts Warnings Cautions Indications For Use Terms Setting up your KardiaMobile® (Model AC-019) hardware for the first time Recording a Six-Lead ECG Recording a Single-Lead ECG ECG Analysis Heart Rate Previously Recorded ECGs Clinical Testing... -
Page 3: Introduction
Kardia app – SW application installed on a compatible smartphone or tablet used to collect, view, and save ECG recordings and to wirelessly transmit to the AliveCor server; Guide to Parts... -
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
AC-019) System can record Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. The KardiaMobile® (Model AC-019) System also displays ECG rhythms and output of ECG analysis from AliveCor’s KardiaAI platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others. The KardiaMobile®... -
Page 6: Setting Up Your Kardiamobile® (Model Ac-019) Hardware For The First Time
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). - Page 7 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.
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Page 8: Recording A Six-Lead Ecg
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. - Page 9 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.
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Page 10: Recording A Single-Lead Ecg
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. - Page 11 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.
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Page 12: Ecg Analysis
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. -
Page 13: Heart Rate
Instructions for Use for KardiaMobile® (Model AC-019) Unclassified Your EKG does not fall into This is not a diagnosis, only the algorithmic classifications a possible finding. Contact a of Normal, Bradycardia, physician if you have Tachycardia, or Atrial questions or are concerned Fibrillation. -
Page 14: Clinical Testing
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. The study showed that the KardiaMobile®... -
Page 15: Maintenance
Inspect electrodes for warping, surface damage, or corrosion o Check for any other form of damage 4. For battery replacement, AliveCor recommends that you bring your KardiaMobile® (Model AC-019) hardware to a watch repair or hearing-aid repair shop. ○ Battery Type: CR2016 Coin Cell that is IEC 60086-4 compliant ○... -
Page 16: Ingress Protection Marking
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. - Page 17 4. Problem: The ECG rhythms appear upside down. Solution ○ Option 1: Make sure the AliveCor logo is in the correct orientation. Make sure your thumbs are touching the 2 top electrodes (left thumb on the Left Hand Electrode and right thumb on the Right Hand Electrode) and the bottom electrode (Left Leg Electrode) is touching the skin above your left knee or your left ankle.
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Page 18: Electrical Safety
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. -
Page 19: Instructions For Use For Kardiamobile® (Model Ac
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. - Page 20 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.
- Page 21 Instructions for Use for KardiaMobile® (Model AC-019) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Page 21 of 23...
- Page 22 Instructions for Use for KardiaMobile® (Model AC-019) Recommended separation distances between portable and mobile RF communications equipment and KardiaMobile® (Model AC- 019) KardiaMobile® (Model AC-019) is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of KardiaMobile® (Model AC-019) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and KardiaMobile®...
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Page 23: Equipment Symbols
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. Type CF Applied Part Do not dispose with household waste Read instructions before use Manufacturer Temperature range Humidity range...