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:

Click here to download the 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 Assessment	Recommendation	Basis
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 Image Medaval 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.