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BIOS BD215 (Precision 8.0)

Device Name:Precision 8.0
Device Model:BD215
Manufacturer:

Distributer: Thermor Ltd., 16975 Leslie Street, Newmarket, Ontario L3Y 9A1, CANADA.

OBL: BIOS Medical, 16975 Leslie Street, Newmarket, Ontario L3Y 9A1, CANADA.

Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Discontinued but still available
Description: The BIOS BD215 (Precision 8.0) is a clinically validated and certified 4-star automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:

The accuracy of the technology used in the BIOS BD215 (Precision 8.0), to measure blood pressure, is certified by Medaval Ltd.

Accuracy AssessmentRecommendationBasis
Medaval★★★★ Certified AccuracyRecent clinical validation; recent protocol with certified adherence
BIHS (UK and IRL)Self-measurementPublished evidence
Hypertension CanadaSelf-measurement (Silver)Published evidence
ESH (Europe)Self-measurementPublished evidence
Stride BPSelf-measurement for adults (Preferred)Published evidence

Validation Publications

Benetti E, Fania C, Márquez Hernández V, Palatini P. Validation of the Thermor BIOS BD215 device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Jun;19(3):176-9. doi: 10.1097/MBP.0000000000000030. PMID: 24589529.

ESH-IP:2010 - Pass General population

Medaval Certification Assessment

Cert ImageMedaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the Thermor BIOS BD-215 upper arm monitor, as validated according to the European Society of Hypertension International Protocol revision 2010. Medical Device Assessment. 2016 Aug 5;2016(1615) 4 p. Epub: 2019 Jan 31. Available from: https://www.medaval.ie/MDA/2016/MDA1615.pdf.

With proven validity of validation results according to an accepted protocol, the clinical accuracy of the blood pressure measurement technology, used in the Thermor BIOS BD-215, is certified by Medaval Ltd.