title: Validation of the custo screen 400 ambulatory blood pressure-monitoring device according to the European Society of Hypertension International Protocol revision 2010.
abstract: OBJECTIVE
  The aim of the present study was to validate the custo screen 400 ambulatory blood pressure-monitoring (ABPM) device according to the 2010 International Protocol revision of the European Society of Hypertension (ESH-IP). The device can be used for ABPM for up to 72 hours.
  
  
  METHODS
  Systolic and diastolic blood pressure (SBP and DBP, respectively) were sequentially measured in 33 adult subjects (13 males and 20 females) and compared with a standard mercury sphygmomanometer (two observers). A total of 99 comparison pairs were obtained.
  
  
  RESULTS
  The custo screen 400 met the requirements of parts 1 and 2 of the ESH-IP revision 2010. The mean difference between the device and reference sphygmomanometer readings was -0.5±4.5 mmHg for SBP and -0.1±3.3 mmHg for DBP. All but one measurement were within the absolute difference of 10 mmHg between the device and the observers for SBP and DBP. The number of absolute differences between the device and the observers within a range of 5 mmHg was 84 of 99 readings for SBP, and 93 of 99 readings for DBP.
  
  
  CONCLUSIONS
  The custo screen 400 ABPM device met the requirements of the 2010 ESH-IP revision, and hence can be recommended for ABPM in adults. To our knowledge, the custo screen 400 is the first device to pass the revised ESH-IP 2010.
authors.affiliation: Institut für Pharmakologie und Präventive Medizin, Cloppenburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
authors.affiliation: Institut für Pharmakologie und Präventive Medizin, Cloppenburg, Germany.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Deutsch
authors.affiliation: Institut für Pharmakologie und Präventive Medizin, Cloppenburg, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Krüger
authors.affiliation: Müller and Sebastiani, Ottobrunn, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Wolf
authors.affiliation: Müller and Sebastiani, Ottobrunn, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Müller
authors.affiliation: Institut für Pharmakologie und Präventive Medizin, Cloppenburg, Germany ; Estimate, Augsburg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Zwingers
authors.affiliation: Institut für Pharmakologie und Präventive Medizin, Cloppenburg, Germany.
authors.forename: Beate
authors.initials: B
authors.lastname: Beime
authors.affiliation: Kerckhoff-Klinik, Bad Nauheim, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Mengden
mesh_terms: D001794:Blood Pressure; D018660:Blood Pressure Monitoring, Ambulatory / Q000295:instrumentation* / Q000592:standards*; D015924:Blood Pressure Monitors / Q000592:standards*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012955:Societies, Medical; D019722:Sphygmomanometers / Q000592:standards
keywords: ESH; ambulatory blood pressure monitoring; validation