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Related Manuals for AliveCor KardiaMobile Card
Summary of Contents for AliveCor KardiaMobile Card
- Page 1 Instructions for Use (IFU) KardiaMobile Card (AC-021) 21LB01.01 December 2021 AliveCor, Inc. 189 N Bernardo Avenue, Suite 100, Mountain View, CA 94043, USA © 2021 AliveCor, Inc. AliveCor and KardiaMobile are registered trademarks of AliveCor, Inc. in the United States and other jurisdictions.
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Page 2: Table Of Contents
Instructions for Use for KardiaMobile Card (AC-021) Table of Contents Introduction Guide to Parts Warnings and Precautions Indications For Use Features & Functionality Setting up your KardiaMobile Card device for the first time Recording an EKG EKG Analysis Heart Rate Environmental Specifications Expected Service Life Maintenance Device Disposal Electromagnetic &... -
Page 3: Introduction
The Kardia app can be downloaded in the App Store or the Google Play Store. 5. The KardiaMobile Card System does not require a Wi-Fi or mobile data connection to record an EKG and save it to the device’s local memory; it does require a connection to sync automatically with the AliveCor server, email, or print directly from the Kardia app. -
Page 4: Guide To Parts
BACK VIEW Warnings and Precautions 1. AliveCor does not guarantee that you are not experiencing an arrhythmia or other health conditions with any EKG result, including normal. You should notify your physician for possible changes in your health or if you are experiencing any concerning symptoms. - Page 5 10. Do not continue use until further instructed by a physician if your skin is irritated or inflamed around the electrode contact area. 11. 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.
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Page 6: Indications For Use
Features & Functionality KardiaMobile Card is a personal EKG device that is capable of recording a Single-Lead EKG. It has two electrodes on the top surface and is powered by a non-replaceable battery. Bluetooth is used to wirelessly transmit EKG data from the device to your smartphone or tablet. -
Page 7: Setting Up Your Kardiamobile Card Device For The First Time
Recording an EKG 1. Open the app and tap "Record your EKG". 2. If this is your first time using the KardiaMobile Card, follow the on-screen instructions to set up and choose your device. 3. Pick up the KardiaMobile Card using your index finger and thumb; and press the power button using your thumb. -
Page 8: Ekg Analysis
8. The device will turn off automatically after use. EKG Analysis Upon completion of your EKG recording the EKG is processed by AliveCor’s Instant Analysis algorithms in the Kardia app. The app will display your full EKG and the Instant Analysis result with description. - Page 9 Instructions for Use for KardiaMobile Card (AC-021) Instant Analysis Description Additional information Bradycardia Your heart rate is less than 50 beats per Kardia does not check for heart minute, which is slower than normal for attack. If you believe you are having most people.
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Page 10: Heart Rate
The expected service life for the KardiaMobile Card is 2 years. Maintenance 1. No service or repair should be performed on the KardiaMobile Card device other than the maintenance listed in this section. To clean the device, wipe with a soft cloth damp with one of the following approved cleaners: a. -
Page 11: Device Disposal
Do not cut, shred or attempt to destroy device. Electromagnetic & Other Interferences KardiaMobile Card has been tested and deemed in conformance with the relevant requirements in IEC 60601-1-2:2014 Class B for Electromagnetic Compatibility (EMC). FCC and Industry Canada (IC) Compliance... -
Page 12: Ingress Protection Marking
1. My KardiaMobile Card is not working. ○ Make sure the Kardia app on your phone is open, the KardiaMobile Card device is selected and is ready to pair. ○ Make sure the amber LED light turns on when you press the white power button (located inside the “A”... - Page 13 Instructions for Use for KardiaMobile Card (AC-021) o When recording, relax your arms and hands to reduce muscle noise. Rest the forearms and hands on a flat surface. Do not apply too much pressure to the electrodes. ○ Avoid close proximity to items that may cause electrical interference (electronic equipment, computers, chargers, routers, etc.)
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Page 14: Electrical Safety
Electrical Safety Guidance and manufacturer's declaration - electromagnetic emissions KardiaMobile Card is intended for use in the electromagnetic environment specified below. The customer or the user of KardiaMobile Card should assure that it is used in such an environment. Emissions test... - Page 15 If the measured field strength in the location in which KardiaMobile Card is used exceeds the applicable RF compliance level above, KardiaMobile Card should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating KardiaMobile Card.
- Page 16 Recommended separation distances between portable and mobile RF communications equipment and KardiaMobile Card KardiaMobile Card is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of KardiaMobile Card can help prevent electromagnetic interference by...
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Page 17: Equipment Symbols
Instructions for Use for KardiaMobile Card (AC-021) Equipment Symbols These symbols may be used in the packaging and other labeling of the KardiaMobile Card device: Symbol Interpretation Symbol Interpretation Refer to instruction Manufacturer manual/booklet Read instructions Do not dispose with...