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
Availability according to Countries or Regions:
Canada
Device Manual:
Description:
The BIOS BD215 (Precision 8.0) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a certified 4-star Medaval rating. Blood pressure measurements are taken from the upper arm. 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. It 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 ★★★★ Certified Accuracy Recent clinical validation; older protocol with certified adherence
BP BIHS (UK and IRL) Self-measurement (Previous) Published evidence
BP Hypertension Canada Self-measurement (Silver) Published evidence
BP ESH (Europe) Self-measurement Published evidence
BP Stride BP Self-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

Certification 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) 5 p. Epub: 2019 Jan 31. Available from: www.medaval.ie.

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.