Qardio QardioArm A100
Device Name:
QardioArm A100
Manufacturer:
Qardio Inc., 28 2nd Street, San Francisco, CA 94105, UNITED STATES.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
United States
Device Manual:
Description:
The Qardio QardioArm A100 is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for professional use.
Assessment:
The technology used in the Qardio QardioArm A100, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★ Recommendation Recent clinical validation; recent protocol
BP BIHS (UK and IRL) Self-measurement Published evidence
BP Stride BP Self-measurement for adults and diabetes mellitus (Preferred) (Not validated in DM) Published evidence
Consumer BodyYear(s)LevelComment
BP Consumer Reports (US) Latest: 2018-2021 Very Good
BP Amazon Best Sellers (US) Latest: 2019 B (3.4 / 5)
Validation Publications:

Chahine MN, Topouchian J, Zelveian P, Hakobyan Z, Melkonyan A, Azaki A, Diab R, Harb A, Asmar R. Validation of BP devices QardioArm® in the general population and Omron M6 Comfort® in type II diabetic patients according to the European Society of Hypertension International Protocol (ESH-IP). Med Devices (Auckl). 2017 Dec 27;11:11-20. doi: 10.2147/MDER.S142126. PMID: 29343992. Available from: PMC5749560. eCollection 2018.

ESH-IP:2010 - Pass General population

Relevant Publications:

Mazoteras Pardo V, Losa Iglesias ME, López Chicharro J, Becerro de Bengoa Vallejo R. The QardioArm App in the Assessment of Blood Pressure and Heart Rate: Reliability and Validity Study. JMIR Mhealth Uhealth. 2017 Dec;5(12):e198. Epub: 2017 Dec 15. doi: 10.2196/mhealth.8458. PMID: 29246880. Available from: PMC5747597.

The reference device used was the Omron M3 (HEM-7200-E). However, this is a major and fundamental violation of the protocol requirements. Despite its claims, this study is simply a comparison of two devices and cannot be considered as a validation according to the ESH-IP protocol.

Mazoteras Pardo V, Becerro de Bengoa Vallejo R, Losa Iglesias ME, López López D, Palomo López P, Rodríguez Sanz D, Calvo Lobo C. The QardioArm Blood Pressure App for Self-Measurement in an Obese Population: Validation Study Using the European Society of Hypertension International Protocol Revision 2010. JMIR Mhealth Uhealth. 2018 Oct;6(10):e11632. Epub: 2018 Oct 25. doi: 10.2196/11632. PMID: 30361193. Available from: PMC6229517.

The reference device used was the Omron M3 Intellisense (HEM-7051-E). However, this is a major and fundamental violation of the protocol requirements. Despite its claims, this study is simply a comparison of two devices and cannot be considered as a validation according to the ESH-IP protocol.

Mazoteras-Pardo V, Becerro-De-Bengoa-Vallejo R, Losa-Iglesias ME, López-López D, Rodríguez-Sanz D, Casado-Hernández I, Calvo-Lobo C, Palomo-López P. QardioArm Upper Arm Blood Pressure Monitor Against Omron M3 Upper Arm Blood Pressure Monitor in Patients With Chronic Kidney Disease: A Validation Study According to the European Society of Hypertension International Protocol Revision 2010. J Med Internet Res. 2019 Dec 2;21(12):e14686. doi: 10.2196/14686. PMID: 31789600.

The reference device used was the Omron M3 Intellisense (HEM-7051-E). However, this is a major and fundamental violation of the protocol requirements. Despite its claims, this study is simply a comparison of two devices and cannot be considered as a validation according to the ESH-IP protocol.

Mazoteras-Pardo V, Becerro-De-Bengoa-Vallejo R, Losa-Iglesias ME, Martínez-Jiménez EM, Calvo-Lobo C, Romero-Morales C, López-López D, Palomo-López P. QardioArm Blood Pressure Monitoring in a Population With Type 2 Diabetes: Validation Study. J Med Internet Res. 2020 Jul 24;22(7):e19781. doi: 10.2196/19781. PMID: 32706672. Available from: PMC7414407.

The reference device used was the Omron M3 Intellisense (HEM-7051-E). However, this is a major and fundamental violation of the protocol requirements. Despite its claims, this study is simply a comparison of two devices and cannot be considered as a validation according to the ESH-IP protocol.