KardiaRx
Médecine
Gratuit
KardiaRx is a prescription only app providing the most advanced cardiac monitoring.
During your monitoring period, the app will work with the FDA-cleared KardiaMobile 6L EKG devices, which can detect the most common arrhythmias in just 30 seconds.
Capture a medical-grade EKG with your Kardia device anytime, anywhere—no patches, wires, or gels required.
The Kardia system is recommended by leading cardiologists and used by people around the world for accurate EKG recordings. Track your heart health data from home with the medical accuracy your doctor can trust.
NOTE: This app requires KardiaMobile 6L and a physician prescription to record an EKG.
Notes et avis
- Cette app n’a pas reçu suffisamment de notes ou d’avis pour en proposer un aperçu.
Support for new additional languages (Malay, Tamil, and Spanish - US), bug fixes, and general performance improvements.
Le développeur AliveCor, Inc. a indiqué que les pratiques de l’app en matière de confidentialité peuvent inclure le traitement des données tel que décrit ci‑dessous. Pour en savoir plus, consultez la politique de confidentialité du développeur .
Données n’établissant aucun lien avec vous
Les données suivantes peuvent être collectées, mais elles ne sont pas liées à votre identité :
- Identifiants
- Données d’utilisation
- Diagnostic
Accessibilité
Le développeur n’a pas encore indiqué quelles fonctionnalités d’accessibilité sont prises en charge par cette app. En savoir plus
Informations
- Taille
- 143,1 Mo
- Catégorie
- Médecine
- Compatibilité
Nécessite iOS 15.0 ou version ultérieure.
- iPhone
Nécessite iOS 15.0 ou version ultérieure. - iPad
Nécessite iPadOS 15.0 ou version ultérieure. - iPod touch
Nécessite iOS 15.0 ou version ultérieure. - Apple Vision
Nécessite visionOS 1.0 ou version ultérieure.
- iPhone
- Langues
Français et 28 de plus
- Français, Allemand, Anglais, Arabe, Bulgare, Chinois simplifié, Chinois traditionnel, Coréen, Croate, Danois, Espagnol, Finnois, Hongrois, Italien, Japonais, Lituanien, Malais, Norvégien, Néerlandais, Polonais, Portugais, Roumain, Russe, Serbe, Slovaque, Suédois, Tamoul, Tchèque, Vietnamien
- Âge
4+
- 4+
- Fournisseur
AliveCor, Inc.
- Le fournisseur AliveCor, Inc. s’est identifié comme commerçant de cette app et a confirmé que ce produit ou service est conforme à la législation de l’Union européenne.
- Numéro DUNS
078523613 - Adresse
189 Bernardo Ave Ste 100
Mountain View California 94043
États-Unis - Téléphone
+1 6502579950 - Adresse e‑mail
alivecor_appleent007@alivecor.com
- Dispositif médical
Yes
- AliveCor, Inc. a indiqué que cette app est un dispositif médical réglementé et qu’elle est conforme à la législation de l’Union européenne.
- Les informations ci‑dessous n’ont pas été validées par Apple.
- SRN du fabricant
- US-MF-000029146
- Adresse
- 189 Bernardo Ave Ste 100
Mountain View California 94043
États-Unis - Numéro de téléphone
- +1 650-257-9950
- E‑mail
- alivecor_appleent007@alivecor.com
- Déclaration d’utilisation
- The KardiaMobile 6L System is intended to record, store and transfer ECG rhythms. The
KardiaMobile 6L System also displays ECG rhythms and output of ECG analysis from
AliveCor’s KardiaAI platform including detecting the presence of normal sinus rhythm, atrial
fibrillation, bradycardia, tachycardia, sinus rhythm with premature ventricular contraction
(PVCs), sinus rhythm with supraventricular ectopy (SVE) and sinus rhythm with wide QRS. - Informations de sécurité
- Contraindications
The KardiaMobile 6L System should not be used by patients with a cardiac pacemaker, Implantable cardioverter-defibrillators (ICDs), or other implanted electronic devices.
The KardiaMobile 6L System is not intended for pediatric use (defined as under 18 years of age), since it has not been tested on this population.
The KardiaMobile 6L System is not intended to be used by unconscious patients or patients unable to hold or interact with the mobile app and hardware.
Warnings
1. KardiaMobile 6L System does not check for a heart attack. A heart attack (myocardial
infarction) is a serious emergency where the blood supply to part of the heart is suddenly
blocked. If you have sudden chest pain or pressure that worries you, or you feel very unwell, do
not rely on the app result. Call emergency services or seek urgent medical care immediately.
2. Several “heart attack” symptoms (e.g., chest discomfort, shortness of breath, palpitations,
dizziness) overlap with anxiety, panic attacks and benign arrhythmias.
2. DO NOT change your medication without talking to your doctor.
3. Detection of possible Atrial Fibrillation (AF) in your ECG results are not to be used for
diagnosis. Contact your physician for final diagnosis.
4. 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".
5. After ECG analysis, the app may incorrectly identify ventricular flutter, ventricular
bigeminy, and ventricular trigeminy heart conditions as unreadable. Please consult with your
physician.
6. AliveCor does not guarantee that you are not experiencing an arrhythmia or other health
conditions with any ECG result, including normal. You should notify your physician for possible
changes in your health. DO use this device to record heart rate and heart rhythm only.
7. DO NOT use to diagnose heart- related conditions.
8. 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.
9. ECG reports viewed at any magnification other than 100% may appear distorted and could
lead to misdiagnosis.
10. DO NOT continue use until further instructed by a physician if your skin is irritated or
inflamed around the electrode.
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. MR-Unsafe. Do not expose the device to a magnetic resonance (MR) environment. The device
may present a risk of projectile injury due to the presence of ferromagnetic materials that can be
attracted by the MR magnet core
14. DO NOT use during cautery and external defibrillation procedures.
15. Keep device away from young children. Contents may be harmful if swallowed. The
KardiaMobile 6L device contains a coin cell battery that is not accessible during normal use but,
if exposed, can be a choking hazard and may cause severe tissue injury if ingested.
Precautions
1. Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State and/or country in which the user
and/or patient is established
2. DO NOT place electrodes in contact with other conductive parts including earth.
4. DO NOT use adjacent to or stacked with other equipment because it could result in
improper operation.
5. DO NOT use portable RF communications equipment (including peripherals such as
antenna cables and external antennas) closer than 30 cm (12 inches) to any part of the
KardiaMobile 6L System. Otherwise, degradation of the performance of the KardiaMobile 6L
System could result.
6. “Unreadable” ECG results determines that you didn't have proper ECG recording for
analysis. You may try to re-record your ECG.
7. Manual ECG analysis is only intended for trained HCPs and lay untrained users should not
analyze an ECG nor make any diagnostic assessments.
8. 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.
9. DO NOT take a recording while driving or during physical activity.
10. DO NOT store in extremely hot, cold, humid, wet, or bright conditions.
11. DO NOT take a recording if electrodes are dirty. Clean them first.
12. DO NOT use alcohol-based or abrasive cleaners and materials as these products could
adversely affect product performance.
- Instructions d’utilisation
- Consultez le site du développeur
- Copyright
- © Copyright 2021 AliveCor, Inc. All Rights Reserved. US Patent No: 8,301,232 and Patents Pending. AliveCor is a registered trademark of AliveCor, Inc. in the United States and other countries.
