Thermor BIOS BD-215

Device Name: BIOS BD-215

Manufacturer:BD-215

Manufacturer Thermor Ltd., 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

Click here to download the Device Manual

Assessment:The technology used in the Thermor BIOS BD-215, 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:

Rezai MR, Goudot G, Winters C, Finn JD, Wu FC, Cruickshank JK. Calibration mode influences central blood pressure differences between SphygmoCor and two newer devices, the Arteriograph and Omron HEM-9000. Hypertens Res. 2011 Sep;34(9):1046-51. Epub: 2011 Jul 14. doi: 10.1038/hr.2011.75. PMID: 21753770. Available from: www.nature.com/hr/journal/v34/n9/full/hr201175a.html.

Measurements from the Tensiomed Arteriograph TL2 are compared to those from the Omron M9000 and the Sphygmocor, though not in a formal validation.