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Instructions for Use for KardiaMobile® (Model AC-019)

Page 2 of 23

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

Environmental Specifications

Expected Service Life

Maintenance

Electromagnetic & Other Interferences

FCC Compliance

Ingress Protection Marking

Applied Parts

Troubleshooting

Electrical Safety

Equipment Symbols

Содержание KardiaMobile AC-019

Страница 1: ...AliveCor is a registered trademark of AliveCor Inc Instructions for Use IFU for KardiaMobile Model AC 019 19LB01 X13 AliveCor Inc 444 Castro Street Mountain View CA 94041 USA AliveCor Inc 2019 ...

Страница 2: ...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 15 FCC Compliance 15 Ingress Protection Marking 16 Applied Parts 16 Troubleshooting 16 Electrical Safety 18 Equipment Symb...

Страница 3: ...dware is used with a user supplied compatible smartphone or tablet 3 The KardiaMobile Model AC 019 System consists of a KardiaMobile Model AC 019 a device that has 3 electrodes to sense and transmit 6 Lead ECG rhythms to the smartphone or tablet and that can optionally attach to your compatible smartphone with the sold separately phone clip b Kardia app SW application installed on a compatible sma...

Страница 4: ... and may cause severe tissue injury if ingested 8 DO NOT replace the battery when device is in use 9 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 10 DO NOT take a recording while driving or during physical activity 11 DO NOT store in extremely hot cold humid wet or bright conditions 12 DO NOT take a r...

Страница 5: ...ys 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 Model AC 019 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 int...

Страница 6: ...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 Tap on your home screen to launch the Kardia app and tap Create Account Follow the onscreen instructions to create an account 4 From the Kardia app home screen tap Record your first ECG 5 Select K...

Страница 7: ...ap 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 ...

Страница 8: ...diologist when possible If you prefer to record a Single Lead ECG follow the instructions in the section Recording a Single Lead ECG 2 Remain still and hold the device with your thumbs on the 2 top electrodes Left Hand Electrode and Right Hand Electrode and touch the bottom electrode Left Leg Electrode to the skin above your left knee or your left ankle NOTE It is recommended that the bottom elect...

Страница 9: ...g 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 NOTE KardiaMobile Model AC 019 may be used up to a distance of 10 feet from the smartphone or tablet 5 Hold steady while you watch the countdown timer decrease from 30 to 0 seconds 6 After ...

Страница 10: ...hen 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 Remain still and hold the device with your thumbs on the 2 top electrodes Left Hand Electrode and Right Hand Electrode Make sure your fingers don t touch the bottom electrode Left Leg Electrode ...

Страница 11: ...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 NOTE KardiaMobile Model AC 019 may be used up to a distance of 10 feet from the smartphone or tablet 5 After 30 seconds you will see your Single Lead ECG with the ECG Ana...

Страница 12: ...a physician if you have questions or are concerned about any symptoms Bradycardia Your heart rate is less than 50 beats per minute which is slower than normal for most people This is not a diagnosis only a possible finding Contact a physician if you have questions or are concerned about any symptoms Normal No rhythm abnormalities are detected in your EKG This is not a diagnosis only a possible fin...

Страница 13: ...uiet location with less interference WARNING After ECG analysis the app may incorrectly identify ventricular flutter ventricular bigeminy and ventricular trigeminy heart conditions as unreadable Please consult with your physician Heart Rate Current heart rate is displayed during an ECG recording and the average heart rate is displayed in completed ECG recordings along with the ECG Analysis The Kar...

Страница 14: ...nt to the same leads on a standard FDA cleared hospital 12 lead ECG device but at an ambulatory bandwidth Clinical equivalence was shown qualitatively through a review by two Board Certified Cardiac Electrophysiologists and quantitatively through a statistical test of equivalence between the two sets of ECGs assessing various variables Environmental Specifications Operational Temperature 10 C to 4...

Страница 15: ... aid repair shop Battery Type CR2016 Coin Cell that is IEC 60086 4 compliant Ensure proper orientation of the battery with battery information and terminal facing up WARNING 1 During replacement keep device away from young children Contents may be harmful if swallowed Device contains a coin cell battery that can be a choking hazard and may cause severe tissue injury if ingested 2 DO NOT replace th...

Страница 16: ... If ambient temperature exceeds 41 C Applied Parts can exceed 41 C Troubleshooting If you experience difficulties in operating your KardiaMobile Model AC 019 System refer to the troubleshooting guide below or contact technical support at support alivecor com 1 Problem My KardiaMobile Model AC 019 is not working Solution Option 1 Make sure you have Bluetooth turned on your smartphone or tablet Opti...

Страница 17: ... you record a Six Lead ECG 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 NOTE It i...

Страница 18: ...ons test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 KardiaMobile Model AC 019 uses RF energy only for its internal function RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B KardiaMobile Model AC 019 is intended for use in domestic surroundings Harmonic emissions IEC 61000 3 2 N A K...

Страница 19: ... air 15 kV air 2 kV contact 4 kV contact 6 kV contact 8 kV contact 2 kV air 4 kV air 8 kV air 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 N A N A KardiaMobile Model AC 019 is powered from a lithium coin cell battery and does not require AC mains power...

Страница 20: ...gths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by abs...

Страница 21: ...Instructions for Use for KardiaMobile Model AC 019 Page 21 of 23 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m ...

Страница 22: ...ated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicab...

Страница 23: ...ymbols 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 Model number Serial number European Authorized Representative ...

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