Sky Labs CART-I plus
Device Name:
CART-I plus
Manufacturer:
Sky Labs Inc., 703 C'S Tower, 58 Pangyo-ro 255beon-gil, Bundang-gu 703, Seongnam-si, Gyeonggi-do 13486, REPUBLIC of KOREA.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for ambulatory blood pressure monitoring
Measurement Site:
Finger
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Availability:
Available Currently
Description:
The Sky Labs CART-I plus is an ambulatory blood pressure monitor. Although its blood pressure measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood pressure measurements are taken from the finger. It is intended for ambulatory blood pressure monitoring.
Assessment:
The technology used in the Sky Labs CART-I plus, to measure blood pressure, has been assessed, in a general population, according to a non-standard protocol.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.
Validation Publications:

Kim J, Chang SA, Park SW. First-in-Human Study for Evaluating the Accuracy of Smart Ring Based Cuffless Blood Pressure Measurement. J Korean Med Sci.. 2024 Jan 15;39(2):e18. doi: 10.3346/jkms.2024.39.e18. PMID: 38225785. Available from: PMC10789523.

Ad Hoc protocol General population (Note: Ad-hoc protocol based on ISO 81060-2:2018. BP Critera based on participants, not measurements. Simultaneous opposite arm comparisons.)

Relevant Publications:

Lee H, Park S, Kwon H, Cho B, Park JH, Lee HY. Feasibility and Effectiveness of a Ring-Type Blood Pressure Measurement Device Compared With 24-Hour Ambulatory Blood Pressure Monitoring Device. Korean Circ J.. 2024 Feb;54(2):93-104. Epub: 2023 Dec 26. doi: 10.4070/kcj.2023.0303. PMID: 38196118. Available from: PMC10864248.

Measurements from the Sky Labs CART-I plus are compared to those from an unidentified ABPM monitor, though not in a formal validation.

Shin JH, Shin J. Evaluation of Applicability and Accuracy of a New Form of Cuffless Blood Pressure Measurement Device, CART-I Plus. Korean Circ J.. 2024 Feb;54(2):105-107. doi: 10.4070/kcj.2024.0016. PMID: 38346697. Available from: PMC10864252.

The publication is a letter or correspondence in which the Sky Labs CART-I plus is referenced.

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