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Instructions for Use for KardiaMobile Card (AC-021) 

 

 

 

 

 

 

 

 

 

 

 

Page 12 of 17 

 

3.   Tap “About Kardia” to view the FCC and IC IDs and other applicable regulatory information. 

Ingress Protection Marking 

KardiaMobile Card is IPX8 rated. KardiaMobile Card is protected against immersion in water up 
to 2 meters for 1 hour. KardiaMobile Card has been tested with relevant requirement standard 
IEC 60601-1-11:2015.  

Applied Parts 

The 2 electrodes (Left Hand Electrode and Right Hand Electrode) are Type BF Applied Parts. 
 
Operational temperature of the device is -10°C to +40°C.  If ambient temperature exceeds 
+41°C, Applied Parts can 41°C. 

Troubleshooting 

If you experience difficulties using your KardiaMobile Card, refer to the troubleshooting guide 
below or contact technical support at 

[email protected]

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” symbol on the right corner of the KardiaMobile Card).

 

  Hold the card between your thumb and index finger with your thumb on the 

front of the device over the power button 

 . Press down firmly with your 

thumb until you see the LED solid light or blinking light (you may also hear a 
click). A blinking LED light indicates that the device is trying to establish a 
connection with your phone/tablet.  

  If the light does not turn on the battery could be depleted.  

If the amber light does turn on:  
○  Make sure Bluetooth is turned on in your smartphone or tablet settings and follow the 

steps on your screen. 

 

○  If Bluetooth is on, try to un-pair and pair again to your KardiaMobile Card.

 

      
2. 

I'm having trouble getting a clear recording.

 

o

  Clean the electrodes using a damp soft cloth.  Wash your hands with soap and water.  

Use a small amount of water to moisten the skin where your fingers make contact with 
the electrodes. 
 

Содержание AC-021

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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