AliveCor AC-021 Manuale di istruzioni per l'uso - Pagina 5

Sfoglia online o scarica il pdf Manuale di istruzioni per l'uso per Apparecchiature mediche AliveCor AC-021. AliveCor AC-021 17.

Instructions for Use for KardiaMobile Card (AC-021)

4. Do not use this device to diagnose heart-related conditions.

5. KardiaMobile Card does not check for heart attack.

6. Detection of possible Atrial Fibrillation (AF) in your EKG results are not to be used for

diagnosis.

7. Result of "Bradycardia" or "Tachycardia" are designations of heart rate in the absence of AF,

and are not to be used for diagnosis. Please consult with your physician should you receive

consistent identifications of "Bradycardia" or "Tachycardia".

8. "Unreadable" EKG result determines that you didn't have proper EKG recording for analysis.

You may try to re-record your EKG.

9. Do not use to self-diagnose heart related conditions. Consult with your physician before

making any medical decision, including altering your use of any drug or treatment. Do not

change or adjust your medication without talking to your doctor.

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. Interpretations made by this device are

potential findings, not a complete diagnosis of cardiac conditions. All interpretations should

be reviewed by a medical professional for clinical decision-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 electrode on a portion of the body with too much body fat, body hair or very

dry skin, as a successful recording may not be possible.

15. Do not take a recording while driving or during physical activity.

16. Do not store in extremely hot, cold, humid, wet, or bright conditions.

17. Do not take a recording if electrodes are dirty. Clean them first (see cleaning instructions

under "Maintenance" section).

18. Do not use abrasive cleaners and materials as these products could adversely affect

product performance.

19. Do not immerse device or expose device to excessive liquid.

20. Do not use while charging your phone.

21. Do not drop or bump with excessive force.

22. Do not expose to strong electromagnetic fields. Do not take recordings when the device is in

close vicinity to strong electromagnetic fields (e.g. electromagnetic anti-theft systems, metal

detectors).

23. Do not expose the device to a magnetic resonance (MR) environment.

24. Do not use with a cardiac pacemaker, ICDs, or other implanted electronic devices.

25. Do not use during a medical procedure (e.g. magnetic resonance imaging, diathermy,

lithotripsy, cautery and external defibrillation procedures).

26. Do not place electrodes in contact with other conductive parts including earth.

27. Do not use with un-approved accessories. Use of non-AliveCor approved accessories or

transducers and cables could result in electromagnetic emissions or decreased

electromagnetic immunity of this device and result in improper operation.

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