AliveCor KardiaMobile 6L Wireless ECG Recorder System Instructions

AliveCor KardiaMobile 6L Wireless ECG Recorder System Instructions

INTENDED USE

The KardiaMobile System is intended to record, store and transfer single- channel electrocardiogram (ECG) rhythms. The KardiaMobile System also displays ECG rhythms and output of ECG analysis from AliveCor’s KardiaAl platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others. The KardiaMobile System is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The device has not been tested and is not intended for pediatric use.

USING KARDIAMOBILE

1. Attach KardiaMobile Hardware to Your Phone (Optional)

   • Remove KardiaMobile Hardware from the box
     NOTE: KardiaMobile does not require calibration prior to use
     

   • If you choose to attach KardiaMo- bile Hardware to the phone, adhere the optional attachment plate to the back of the phone
     NOTE: If the device is attached to your phone remove it prior to wirelessly charging the phone. DO NOT place the device on top of your phone while wirelessly charging the phone.

   • While holding the phone upright (camera at top), slide KardiaMo- bile Hardware into the attachment plate so that the logo is pointing to the right “>”.

NOTE: KardiaMobile Hardware may be used up to a distance of 30 cm (1 ft.) from the smartphone or tablet. You have the option of adhering it to the phone

2. Download Kardia App & Create an Account

   • On your compatible iOS or Android Phone (www.alivecor. com/compatibility), download the Kardia app from the App Store or Google Play
   • Open the Kardia app and follow the onscreen instructions to create an account.

3. Recording your first ECG
   Do not use KardiaMobile System while charging your phone.
   Do not take a recording while driving or during physical activity
   Do not take a recording if the electrodes are dirty. Clean them first

   • Tap the Kardia app on your phone to open the application.

   • Rest two or more fingers on KardiaMobile Hardware; your right hand should contact the sensor (electrode) closest to the bottom of the smartphone, and your left hand should contact the electrode closest to the top of the
     

   • Rest your arms on a flat surface. Remain still with your fingers on the electrodes for 30 sec

4. ECG Analysis

• After ECG recording is complete, the ECG is analyzed to determine if it is at least 30 seconds long, if it is Normal, Unclassified, possible Atrial Fibrillation, Tachycardia or Bradycardia or if it is too noisy to interpret.
• The presence of possible Atrial Fibrillation (AF) in your ECG results may present only potential findings. If you are experiencing any symptoms or have concerns, contact your physician.
• Normal results mean your heart rate is between 50 and 100 beats per minute, and shape, timing and duration of each beat is considered normal.
• Bradycardia results mean your heart rate is between 40 and 50 beats per minute, and shape, timing and duration of each beat is considered normal.
• Tachycardia results mean your heart rate is between 100 and 140 beats per minute, and shape, timing and duration of each beat is considered normal.
• An Unclassified message means the tracing is not Normal,  AF, Tachycardia or Bradycardia and interference was not detected. An example of an Unclassified tracing is one where tachycardia is observed.
• Unreadable ECG results determine that you didn’t have proper ECG recording for analysis. You may try to re-record your ECG.
• EOG reports viewed at any magnification other than 100% may appear distorted and could lead to misdiagnosis.

TROUBLESHOOTING

If you experience difficulties in operating your Kardia products, refer to the troubleshooting guide below or contact technical support at support@alivecor.com.

CAUTIONS

General

• DO NOT store in extremely hot, cold, humid, wet, or bright conditions.
• DO NOT expose to strong electromagnetic fields.
• DO NOT take recordings in close vicinity to other equipment emitting ultrasonic acoustics.
• DO keep components out of reach of children.
• DO use this device to record heart rate and heart rhythm only
• DO NOT use the electrode on a portion of the body with too much body fat, body hair or very dry skin, a successful recording may not be possible

KardiaMobile System

• DO NOT use with a cardiac pacemaker, ICDs, or other implanted electronic devices.
• DO NOT continue use until further instructed by a physician if your skin is irritated or inflamed around the sensor.
• DO NOT drop or bump with excessive force.
• DO NOT use to diagnose heart-related conditions.
• DO NOT wear during magnetic resonance imaging (MRI), cautery and external defibrillation procedures.
• DO NOT change your medication without talking to your doctor
• After ECG analysis, the app may incorrectly identify ventricular flutter, ventricular bigeminy, and ventricular trigeminy heart conditions as unreadable. Please consult with your physician

CAUTION: 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

KARDIAMOBILE HARDWARE SPECIFICATIONS
Battery: Coin Cell
Storage Conditions: Original package under normal room temperature and humidity

ELECTROMAGNETIC & OTHER INTERFERENCES
KardiaMobile Hardware has been tested and deemed in conformance with the relevant requirements in EN60601-1-2:2007 Class B for Electromagnetic Compatibility (EMC).

EQUIPMENT SYMBOLS

• Type CF Applied Part
• Do not dispose with household waste
• Read instructions before use
• Manufacturer
• Temperature range

• Humidity range
• Model Number
• Serial Number
• European Authorized Representative
• European Importer

ADDITIONAL INFORMATION
For more detailed troubleshooting and technical information, please visit: https://www.alivecor.com//quickstart

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