BIOS 3MS1-4Y (Precision 10.0 - Ultra)
Device Name:
Precision 10.0 and Ultra
Device Model:
3MS1-4Y
Manufacturer:
Distributer: Thermor Ltd., 16975 Leslie Street, Newmarket, Ontario L3Y 9A1, CANADA.
OBL: BIOS Medical, 16975 Leslie Street, Newmarket, Ontario L3Y 9A1, CANADA.
OEM: Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN ROC.
Measuring functions:
Blood Pressure, PR and Atrial fibrillation
Primary Client Use:
Intended for self-measurement and home use with atrial fibrillation detection
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Canada
Description:
The BIOS 3MS1-4Y (Precision 10.0 - Ultra) is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. With atrial fibrillation detection, it is intended for self-measurement and home use.
Assessment:
While the technology used in the BIOS 3MS1-4Y (Precision 10.0 - Ultra), to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4, but there is no evidence provided on a validation of the other device.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Not recommended | This device has not been shown to have been clinically validated. |
| BP | Hypertension Canada | Self-measurement (Gold) | Manufacturer declaration of equivalence |
Device Family:
, BIOS BD350 aka 3MS1-4K (Precision 10.0 - Ultra) (V3), BIOS BD350 aka 3MS1-4K (Precision 10.0 - Ultra) (V2), BIOS 3MS1-4Y (Precision 10.0 - Ultra), BIOS BD350 (Precision 10.0 - Ultra) (V1), BIOS BD350 (V4)