BIOS Precision 8.0 (BD215)

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

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. Epub: 2016 Aug 5(15):4 p.

The blood pressure measurement technology, used in the Thermor BIOS BD-215, is certified by Medaval Ltd.

Relevant Publications

Feenstra RK, Allaart CP, Berkelmans GFN, Westerhof BE, Smulders YM. Accuracy of oscillometric blood pressure measurement in atrial fibrillation. Blood Press Monit. Epub: 2017 Dec 17. doi: 10.1097/MBP.0000000000000305. PMID: 29256921.

The publication describes the BMEYE Nexfin being used as a validation control device.