Medicare Lifesense A2 (MD638)
Device Name:
Lifesense A2
Device Model:
MD638
Manufacturer:
Fleming Medical Ltd., Corcanree Business Park, Dock Road, Limerick, IRELAND.
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
Availability according to Countries or Regions:
Ireland
Description:
The Medicare Lifesense A2 (MD638) 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 self-measurement and home use.
Assessment:
While the technology used in the Medicare Lifesense A2 (MD638), 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 the results of the assessment on which the declaration has been based have not been published either and cannot be verified. However, there are validation studies proving clinical validation of the same measurement technology, according to other equivalence claims.
Recommendations:
| Accuracy Assessment | Recommendation | Basis |
| BP |
Medaval |
None |
Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP |
BIHS (UK and IRL) |
Self-measurement |
Implied equivalence to the Health & Life HL888HA |
Device Family:
Cresta BPM610B,
Cresta BPM701B,
Medicare Lifesense A2 (MD638)B,
H&L HL858BAB,
H&L HL858GAB,
H&L HL858HAB,
H&L HL868ZAB,
H&L HL868ZBB,
H&L HL888HAB,
H&L HL888HCB,
H&L Airssential AI-H971B,
H&L HL858DKB,
Maestro HL858JAB,
Maestro HL858SAB,
Health Assure HL858JAB,
Medisana BU 582 (51582)Y,
Proton PHC-888EAB,
Proton PHC-888UPB,
Seagull S-888HAB,
Walgreens WGNBPA-730B,
Walgreens WGNBPA-740B,
Walgreens WGNBPA-750BLegend:
B BIHS Derivative,
Y Internal declaration 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.
H&L HL888HA
de Greeff A, Shennan AH. The Health and Life device (HL888HA): accuracy assessment in an adult population according to the British Hypertension Society protocol. Blood Press Monit. 2007 Apr;12(2):107-11. PMID: 17353654.
BHS:1993 - Pass (A/A) General population
Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.
DHL:1999 - Pass General population (Note: 2003)
