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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 and PR
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 AssessmentRecommendationBasis
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 (Previous) Implied equivalence to the H&L HL888HA
Device Family:
Cresta BPM610B, Cresta BPM701B, Medicare Lifesense A2 (MD638)B, H&L HL858BAB, H&L HL858GAB, H&L HL858GT TalkingP, H&L HL858HAB, H&L HL868ZAB, H&L HL868ZBB, H&L HL888HAB, H&L HL888HCB, H&L Airssential AI-H971B, H&L HL868EDP, H&L HL858DKB, H&L HL858A2-TP, Maestro HL858JAB, Maestro HL858SAB, Health Assure HL858JAB, Medisana BU 582 (51582)P,Y, Proton PHC-888EAB, Proton PHC-888UPB, Seagull S-868EDP, Seagull S-888HAB, Seagull S-858DKP, Walgreens WGNBPA-730B, Walgreens WGNBPA-740B, Walgreens WGNBPA-750B
Legend: B BIHS Derivative, P Stride Equivalence, 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 HL868ED

Zhang W, Lei L, Li Y, Wang JG. Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the British Hypertension Society Protocol. Blood Press Monit. 2019 Aug;24(4):203-207. Epub: 2019 May 23. doi: 10.1097/MBP.0000000000000384. PMID: 31136322. Erratum in: Blood Press Monit. 2021 Feb;26(1):85.

BHS:1993 - Pass (A/A) General population

Zhang W, Lei L, Li Y, Wang JG. Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2020 Feb;25(1):53-57. Epub: 2019 Oct. doi: 10.1097/MBP.0000000000000411. PMID: 31658108. Erratum in: Blood Press Monit. 2021 Feb;26(1):84.

ESH-IP:2010 - Pass General population

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)

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