AliveCor AC-021 Instructions For Use Manual Download Page 1

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AliveCor and KardiaMobile are registered trademarks of AliveCor, Inc. in the United States and other jurisdictions.

Instructions for Use (IFU)

for

KardiaMobile Card (AC-021)

21LB01.01

December 2021

AliveCor, Inc.

189 N Bernardo Avenue, Suite 100,

Mountain View, CA 94043, USA

Summary of Contents for AC-021

Page 1: ...trademarks of AliveCor Inc in the United States and other jurisdictions Instructions for Use IFU for KardiaMobile Card AC 021 21LB01 01 December 2021 AliveCor Inc 189 N Bernardo Avenue Suite 100 Moun...

Page 2: ...ionality 6 Setting up your KardiaMobile Card device for the first time 7 Recording an EKG 7 EKG Analysis 8 Heart Rate 10 Environmental Specifications 10 Expected Service Life 10 Maintenance 10 Device...

Page 3: ...your heart rhythm is provided upon completion of your EKG recording See the EKG Analysis section for more details 4 KardiaMobile Card requires a compatible smartphone or tablet and the Kardia app a T...

Page 4: ...ny EKG result including normal You should notify your physician for possible changes in your health or if you are experiencing any concerning symptoms 2 Chest pain or pressure is a medical emergency H...

Page 5: ...making 12 The device has not been tested for and is not intended for pediatric use 13 Device contains a lithium manganese dioxide battery that is not removable or replaceable 14 Do not use the electr...

Page 6: ...ard 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 ped...

Page 7: ...evice list at www alivecor com compatibility 3 Make sure Bluetooth is turned on in your smartphone or tablet settings 4 Launch the Kardia app and tap Create Account 5 Follow the on screen instructions...

Page 8: ...G recording is complete 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 Kard...

Page 9: ...recordings shorter than 30 seconds Record a new EKG Try to relax and hold still rest your arms or move to a quiet location that will allow for a full 30 second recording Unclassified Atrial fibrillat...

Page 10: ...favorably compared to Lead I recordings of a standard FDA cleared 12 lead device Clinical equivalence of recordings from these Kardia devices and the 12 lead EKG device were also validated by board c...

Page 11: ...ces 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: ...s 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 symbol on the right corner of the...

Page 13: ...recording Ensure that the Enhanced Filter is on Make sure Mains Filter is set appropriately for your geographical location This can be adjusted under the Kardia app Settings 3 On my EKG the recording...

Page 14: ...immunity 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 Im...

Page 15: ...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 symb...

Page 16: ...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...

Page 17: ...Symbol Interpretation Manufacturer Refer to instruction manual booklet Read instructions before use Do not dispose with household waste Temperature range Do not cut shred or attempt to destroy device...