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BpTru BPM-100

Device Model:BPM-100
Manufacturer:

OBL: BpTru (Suspended?), Unit 1, 1850 Hartley Avenue Coquitlam, BC Canada V3K 7, CANADA.

OEM: VSM MedTech Ltd. (Suspended?), 9 Burbidge Street, Coquitlam, British Columbia V3K 7B2, CANADA.

Measuring functions:Blood pressure
Primary Client Use:Intended for professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single and repeated measurements
Availability:Available Currently
Assessment:

The technology used in the BpTru BPM-100, to measure blood pressure, is among the best rated for accuracy by Medaval Ltd. It has passed in four clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★★ RecommendationRecent clinical validation; recent protocol; multiple clinical validations
BIHS (UK and IRL)Professional usePublished evidence
ESH (Europe)Professional use in adults and childrenPublished evidence
AMA VDL CriteriaGeneral use510(k) K994423 plus
MDR CriteriaPossibly in pregnancyResults not in abstract

Device Family:BpTru BPM-200B, BpTru BPM-300B (B BIHS Derivative)
Validation Publications

Mattu GS, Perry TL Jr, Wright JM. Comparison of the oscillometric blood pressure monitor (BPM-100(Beta)) with the auscultatory mercury sphygmomanometer. Blood Press Monit. 2001 Jun;6(3):153-9. PMID: 11518839.

SP10:1996 - Pass General population

BHS:1993 - Pass (A/A) General population

Wright JM, Mattu GS, Perry Jr TL, Gelferc ME, Strange KD, Zorn A, Chen Y. Validation of a new algorithm for the BPM-100 electronic oscillometric office blood pressure monitor. Blood Press Monit. 2001 Jun;6(3):161-5. PMID: 11518840.

SP10:1996 - Pass General population

BHS:1993 - Pass (A/A) General population

Mattu GS, Heran BS, Wright JM. Comparison of the automated non-invasive oscillometric blood pressure monitor (BpTRU) with the auscultatory mercury sphygmomanometer in a paediatric population. Blood Press Monit. 2004 Feb;9(1):39-45. PMID: 15021077.

SP10:1992 - Pass Children 3y to 18y (n=162/36)

BHS:1993 - Pass (B/B) Children 3y to 18y (n=162/36)

Mattu GS, Heran BS, Wright JM. Overall accuracy of the BpTRU--an automated electronic blood pressure device. Blood Press Monit. 2004 Feb;9(1):47-52. PMID: 15021078.

BHS:1993 - Pass (A/A) General population

SP10:2002 - Pass General population

Tran K, Potts J, Purkiss S, Robertson J, Khan N, Padwal R, Chan WS. Validation of an Automated Office Blood Pressure Machine in Pregnant Women According to the AAMI 2013/ISO Protocol. Hypertension. 2018 Dec;72(6):e91-e94. Epub: 2018 Oct 22. doi: 10.1161/HYPERTENSIONAHA.118.12085. PMID: 30571239. Research Letter.

81060-2:2013 General Pregnancy

The actual device and results are unclear from the section available publicly.

Relevant Publications

Brothwell S, Dutton M, Ferro C, Stringer S, Cockwell P. Optimising the accuracy of blood pressure monitoring in chronic kidney disease: the utility of BpTRU. BMC Nephrol. 2013 Oct 10;14:218. doi: 10.1186/1471-2369-14-218. PMID: 24112304. Available from: PMC3852944.

Measurements from the BpTru BPM-100 are compared to those from the Dinamap Pro400 and the ABPM-04, though not in a formal validation.