Custo Med custo screen Pediatric
Device Name:
custo screen Pediatric
Manufacturer:
custo med GmbH, Maria-Merian-Straße 6, D-85521 Ottobrunn, GERMANY.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for ambulatory blood pressure monitoring
Measurement Site:
Upper Arm
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Availability:
Available Currently
Description:
The Custo Med custo screen Pediatric is an ambulatory blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for ambulatory blood pressure monitoring.
Assessment:
The technology used in the Custo Med custo screen Pediatric, to measure blood pressure, has passed in a clinical validation study, in a young population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval Recommended for children only Validation in children
BP ESH (Europe) ABPM for children Published evidence
BP Stride BP ABPM for children (Preferred) Published evidence
Device Family:
Custo Med custo screen 300P,X, Custo Med custo screen 400X, Custo Med custo screen PediatricP, Custo Med custo screen 310P
Legend: P Stride Equivalence, X Equivalence claim in publication
Validation Publications:

Beime B, Deutsch C, Krüger R, Wolf A, Müller P, Hammel G, Bramlage P. Validation of the custo screen pediatric blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. Eur J Pediatr. 2017 May;176(5):573-80. Epub: 2017 Feb 24. doi: 10.1007/s00431-017-2874-3. PMID: 28236027.

ESH-IP:2010 - Pass Children, aged 3 to 12 years (n=33)

Validation Publications for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Custo Med custo screen 400

Bramlage P, Deutsch C, Krüger R, Wolf A, Müller P, Zwingers T, Beime B, Mengden T. Validation of the custo screen 400 ambulatory blood pressure-monitoring device according to the European Society of Hypertension International Protocol revision 2010. Vasc Health Risk Manag. 2014 May 13;10:303-9. doi: 10.2147/VHRM.S63602. PMID: 24868162. Available from: PMC4027883.

ESH-IP:2010 - Pass General population

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