Spacelabs 90202
Device Model:
90202
Manufacturer:
Spacelabs Healthcare, 35301 SE Center St., Snoqualmie, WA 98065, UNITED STATES.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for ambulatory blood pressure monitoring
Measurement Site:
Upper Arm
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Availability:
Obsolete
Description:
The Spacelabs 90202 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. This device is now obsolete.
Assessment:
The technology used in the Spacelabs 90202, 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 Legacy approval Older clinical validation; older protocol
BP FDA (US) 510(k) 510(k) K855127
Validation Publications:

Santucci S, Cates EM, James GD, Schussel YR, Steiner D, Pickering TG. A comparison of two ambulatory blood pressure monitors, the Del Mar Avionics Pressurometer IV and the Spacelabs 90202. Am J Hypertens. 1989 Oct;2(10):797-9. PMID: 2803673.

Ad Hoc protocol General population (Note: (n=48))

Groppelli A, Omboni S, Ravogli A, Villani A, Parati G, Mancia G. Validation of the SpaceLabs 90202 and 90207 devices for ambulatory blood pressure monitoring by comparison with intra-arterial resting and ambulatory measurements. J Hypertens. 1991 Dec;9(Suppl 6):S334-5. PMID: 1818988.

IA protocol General population (Note: No abstract online)

O'Brien E, Mee F, Atkins N, O'Malley K. Evaluation of the SpaceLabs 90202 non-invasive ambulatory recorder according to the AAMI Standard and BHS criteria. J Hum Hypertens. 1991 Jun;5(3):223-6. PMID: 1920345.

BHS:1990 - Pass (B/B) General population

SP10:1987 - Pass General population

Barthélémy JC, Geyssant A, Auboyer C, Antoniadis A, Berruyer J, Lacour JR. Accuracy of ambulatory blood pressure determination: a comparative study. Scand J Clin Lab Invest. 1991 Sep;51(5):461-6. PMID: 1947731.

IA protocol General population

Groppelli A, Omboni S, Parati G, Mancia G. Evaluation of noninvasive blood pressure monitoring devices Spacelabs 90202 and 90207 versus resting and ambulatory 24-hour intra-arterial blood pressure. Hypertension. 1992 Aug;20(2):227-32. PMID: 1639465.

Ad Hoc protocol General population (Note: IA validation)

Relevant Publications:

White WB, Lund-Johansen P, Omvik P. Assessment of four ambulatory blood pressure monitors and measurements by clinicians versus intraarterial blood pressure at rest and during exercise. Am J Cardiol. 1990 Jan 1;65(1):60-66. doi: 10.1016/0002-9149(90)90026-w. PMID: 2294682.

At rest, non-invasive ambulatory BP monitors are similar in accuracy to clinicians in BP determination but during exercise there are differences among the monitors that make some of them unsuitable for measurements while in motion.

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