Omron M24/7 (ABPM-BP5)
Device Name:
M24/7
Device Model:
ABPM-BP5
Manufacturer:
OBL: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
OEM: Meditech Ltd., Mikszath Kalman utca 24, 1184 Budapest, HUNGARY.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for ambulatory blood pressure monitoring
Measurement Site:
Upper Arm
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Availability:
Discontinued but still available
Availability according to Countries or Regions:
Ireland
Device Manual:
Description:
The Omron M24/7 (ABPM-BP5) is an ambulatory 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 ambulatory blood pressure monitoring. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
While the technology used in the Omron M24/7 (ABPM-BP5), to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, 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.
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) | Previous recommendation, now archived | Manufacturer declaration of equivalence |
| BP | ESH (Europe) | ABPM | The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria. |
Device Family:
BIOS ABP-01Z, BTL Cardiopoint BTL-08 ABPM (V1)B, Meditech ABPM-04B,D, Meditech ABPM-05B,D, Meditech card(X)ploreD, Omron M24/7 (ABPM-BP5)B, VectraCor ABPM-05Z
Legend: B BIHS Derivative, D DET Equivalence, Z Almost Certain
Legend: B BIHS Derivative, D DET Equivalence, Z Almost Certain
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.
Meditech ABPM-04
Barna I, Keszei A, Dunai A. Evaluation of Meditech ABPM-04 ambulatory blood pressure measuring device according to the British Hypertension Society protocol. Blood Press Monit. 1998;3(6):363-8. PMID: 10212378.
BHS:1993 - Pass (B/B) General population
SP10:1992 - Pass General population