The technology used in the SpaceLabs 90217, to measure blood pressure, has passed in two clinical validation studies, between general and young populations, according to recognised standard protocols, as published in peer-reviewed publications.
|Medaval||★★ Recommendation||Recent clinical validation; older protocol; multiple clinical validations|
|BIHS (UK and IRL)||ABPM||Published evidence|
|ESH (Europe)||ABPM||Published evidence|
|AMA VDL Criteria||General use||510(k) K103732 plus BHS:1993 validation|
Baumgart P, Kamp J. Accuracy of the SpaceLabs Medical 90217 ambulatory blood pressure monitor. Blood Press Monit. 1998 Oct;3(5):303-307. PMID: 10212370.
BHS:1993 - Pass (A/A) General population
SP10:1992 - Pass General population (Note: Standing, sitting and supine positions)
Redwine KM, James LP, O’Riordan MA, Sullivan JE, Blumer JL; for the Network of Pediatric Pharmacology Research Units. Accuracy of the Spacelabs 90217 ambulatory blood pressure monitor in a pediatric population. Blood Press Monit. 2015 Oct;20(5):295-8. doi: 10.1097/MBP.0000000000000132. PMID: 26529437.
BHS:1993 - Pass (A/B) Children 6y to 17y (n=112)
Amoore JN, Dewar D, Gough K, Padfield PL. Do SpaceLabs ambulatory non-invasive blood pressure recorders measure blood pressure consistently over several years use? Blood Press Monit. 2005 Feb;10(1):51-6. PMID: 15687874.
Measurements from the SpaceLabs 90217 are compared to those from a simulator, though not in a formal validation.
Pang TC, Brown MA. Accuracy of ambulatory blood pressure monitors in routine clinical practice. Am J Hypertens. 2006 Aug;19(8):801-9. PMID: 16876678.
Measurements from the Spacelabs 90217 are compared to those from a standard mercury sphygmomanometer (retrospectively), though not in a formal validation.