A&D UA-1200CNBLE - 1200 UltraConnect
Device Name:
LifeSource 1200 UltraConnect
Device Model:
UA-1200CNBLE
Manufacturer:
A&D Company Ltd., 3-23-14 Higashi-Ikebukuro, Toshima-Ku, 170-0013 Tokyo, JAPAN.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for both professional use and self-measurement
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Canada
Device Manual:
Description:
The A&D UA-1200CNBLE - 1200 UltraConnect is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for both professional use and self-measurement.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the A&D UA-1200CNBLE - 1200 UltraConnect to measure blood pressure. However, this device appears to be very similar to a validated device by the same manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | Hypertension Canada | Self-measurement (Gold) | Manufacturer declaration of equivalence |
Device Family:
Validation Publications for Equivalent Devices:
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
A&D UA-1200BLE
Kario K, Saito K, Sato K, Hamasaki H, Suwa H, Okura A, Hoshide S. Validation of the A&D BP UA-1200BLE device for home blood pressure measurement according to the ISO 81060-2: 2013 standard. Blood Press Monit. 2018 Dec;23(6):312-314. Epub: 2018 Sep 7. doi: 10.1097/MBP.0000000000000347. PMID: 30199378.
81060-2:2013 - Pass General population