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BpTru BPM-300

Device Model:BPM-300
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, Temperature
Primary Client Use:Intended for professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single and repeated measurements
Availability:Available Currently
Assessment:

While the technology used in the BpTru BPM-300, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Previous recommendation, now archivedManufacturer declaration of equivalence
ESH (Europe)Professional use for adults and childrenThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Device Family:BpTru BPM-100B, BpTru BPM-200B, BpTru BPM-300B (B BIHS Derivative)
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.

BpTru BPM-100

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.